Prosthetic valve with radially-deflectable tissue anchors

ABSTRACT

Embodiments of the present disclosure are directed to prosthetic valves and methods of use thereof. In one implementation, an expandable annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are radially constrained, such as within a delivery device, and a deployed configuration, in which they may deflect radially outward. The anchoring legs may deflect radially outward by less than 90° when transitioning from the delivery configuration to the deployed configuration. Portions of the anchoring arms may deflect radially outward by at least 90° when transitioning from the delivery configuration to the deployed configuration.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/541,783, filed Jul. 6, 2017, which issued as U.S. Pat. No. 9,974,651on May 22, 2018, which is a U.S. national stage entry under 35 U.S.C. §371 of International Application No. PCT/IL2016/050125, filed Feb. 3,2016, which claims priority from U.S. Provisional Patent Application No.62/112,343, filed Feb. 5, 2015, all of which are hereby incorporated byreference in their entirety.

FIELD OF THE INVENTION

Some embodiments of the present invention relate in general to valvereplacement. More specifically, some embodiments of the presentinvention relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilatation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

For some embodiments of the present invention, an implant is providedhaving a tubular portion, an upstream support portion and one or moreflanges. The implant is percutaneously deliverable to a native heartvalve in a compressed state, and is expandable at the native valve. Theimplant and its delivery system facilitate causing the upstream supportportion and the flanges to protrude radially outward from the tubularportion without expanding the tubular portion. Expansion of the tubularportion brings the upstream support portion and the flanges closertogether, for securing the implant at the native valve by sandwichingtissue of the native valve between the upstream support portion and theflanges.

In accordance with an embodiment of the present invention, an apparatusis provided for use with a native valve that is disposed between anatrium and a ventricle of a heart of a subject, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the tubular portion defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe: including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements (i) coupledto the ring at a respective peak, and (ii) fixed with respect to arespective valve-frame coupling element, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the outer-frame coupling elements to the valve-framecoupling elements is such that compression of the tubular portion fromthe expanded state toward the compressed state such that the valve-framecoupling elements pull the outer-frame coupling elements radiallyinward: (i) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) increases the amplitude of the pattern of the ring.

In an embodiment, the ring circumscribes the tubular portion.

In an embodiment, the valve-frame coupling elements are disposedcircumferentially around the longitudinal axis between the upstream endand the downstream end but not at the upstream end nor at the downstreamend.

In an embodiment, the upstream support portion includes one or morefabric pockets disposed circumferentially, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the outer frame is coupled to the valve frame only viathe fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In an embodiment, the apparatus further includes an upstream supportportion that includes a plurality of arms that extend radially from thetubular portion, and the upstream support portion has (i) aconstrained-arm state, and (ii) a released-arm state in which the armsextend radially outward from the tubular portion, each leg has atissue-engaging flange that has (i) a constrained-flange state, and (ii)a released-flange state in which the flange extends radially outwardfrom the tubular portion, and the apparatus has an intermediate state inwhich (i) the tubular portion is in its compressed state, (ii) theupstream support portion is in its released-arm state, and (iii) thelegs are in their released-flange state.

In an embodiment, the apparatus includes an implant that includes thevalve frame, the leaflets, and the outer frame, and the apparatusfurther includes a tool: including a delivery capsule dimensioned (i) tohouse and retain the implant in a compressed state of the implant inwhich (a) the tubular portion is in its compressed state, (b) theupstream support portion is in its constrained-arm state, and (c) thelegs are in their constrained-flange state, and (ii) to be advancedpercutaneously to the heart of the subject while the implant is housedand in its compressed state, and operable from outside the subject to:transition the implant from its compressed state into the intermediatestate while retaining the tubular portion in its compressed state, andsubsequently, expand the tubular portion toward its expanded state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the legs into their released-flange state, whileretaining the tubular portion in its compressed state, and (ii)subsequently, releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state.

In an embodiment, the tool is operable from outside the subject totransition the implant from its compressed state into the intermediatestate by (i) releasing the upstream support portion into itsreleased-arm state, while retaining the tubular portion in itscompressed state, and (ii) subsequently, releasing the legs into theirreleased-flange state, while retaining the tubular portion in itscompressed state.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from itscompressed state toward its expanded state moves the flangeslongitudinally away from the valve-frame coupling elements.

In an embodiment, the fixation of the outer-frame coupling elements tothe valve-frame coupling elements is such that, when the apparatus is inits intermediate state, expansion of the tubular portion from acompressed state toward an expanded state reduces the amplitude of thepattern of the ring and passes the flanges between the arms.

In an embodiment, the upstream support portion further includes acovering that covers the arms to form an annular shape in thereleased-arm state, and, when the apparatus is in its intermediatestate, expansion of the tubular portion from its compressed state towardits expanded state presses the flanges onto the covering.

In an embodiment, in the compressed state of the tubular portion, adownstream end of each leg of the tubular portion is longitudinallycloser than the valve-frame coupling elements to the downstream end, andthe flange of each leg is disposed longitudinally closer than thevalve-frame coupling elements to the upstream end.

In an embodiment, in the expanded state of the tubular portion, thedownstream end of each leg is longitudinally closer than the valve-framecoupling elements to the downstream end, and the flange of each leg isdisposed longitudinally closer than the valve-frame coupling elements tothe upstream end.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus having an implant that includes: a valve frame that includes atubular portion that circumscribes a longitudinal axis of the valveframe so as to define a lumen along the axis, the tubular portion havingan upstream end, a downstream end, a longitudinal length therebetween,and a diameter transverse to the longitudinal axis; a valve member,coupled to the tubular portion, disposed within the lumen, and arrangedto provide unidirectional upstream-to-downstream flow of blood throughthe lumen; an upstream support portion, coupled to the tubular portion;and an outer frame, coupled to the tubular portion, and including atissue-engaging flange, and: the implant has a first state and a secondstate, in both the first state and the second state, (i) the upstreamsupport portion extends radially outward from the tubular portion, and(ii) the tissue-engaging flange extends radially outward from thetubular portion, and the tubular portion, the upstream support portion,and the outer frame are arranged such that transitioning of the implantfrom the first state toward the second state: increases the diameter ofthe tubular portion by a diameter-increase amount, decreases the lengthof the tubular portion by a length-decrease amount, and moves the flangea longitudinal distance toward or toward-and-beyond the upstream supportportion, the distance being greater than the length-decrease amount.

In an embodiment of the present invention, the tubular portion, theupstream support portion, and the outer frame may be arranged such thatthe longitudinal distance is more than 20 percent greater than thelength-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 30 percent greater than the length-decrease amount.

In an embodiment, the tubular portion, the upstream support portion, andthe outer frame may be arranged such that the longitudinal distance ismore than 40 percent greater than the length-decrease amount.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis; a plurality of prosthetic leaflets, coupled to the frame, disposedwithin the lumen, and arranged to provide unidirectional flow of bloodfrom an upstream end of the lumen to a downstream end of the lumen; anouter frame, including: a ring defined by a pattern of alternating peaksand troughs: the peaks being longitudinally closer than the troughs tothe upstream end, the peaks being fixed to respective sites of thetubular portion at respective coupling points disposed circumferentiallyaround the longitudinal axis, and the pattern of the ring having anamplitude longitudinally between the peaks and the troughs; and aplurality of legs, each of the legs coupled to the ring at a respectivetrough, and: the tubular portion has (i) a compressed state in which thetubular portion has a compressed diameter, and (ii) an expanded state inwhich the tubular portion has an expanded diameter that is greater thanthe compressed diameter, and the fixation of the peaks to the respectivesites of the tubular portion is such that compression of the tubularportion from the expanded state toward the compressed state such thatthe respective sites of the tubular portion pull the peaks radiallyinward via radially-inward tension on the coupling points: (i) reduces acircumferential distance between each of the coupling points and itsadjacent coupling points, and (ii) increases the amplitude of thepattern of the ring.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve that is disposed between an atrium and aventricle of a heart of a subject is provided, the apparatus including:a valve frame, including a tubular portion that circumscribes alongitudinal axis of the valve frame so as to define a lumen along theaxis, the valve frame defining a plurality of valve-frame couplingelements disposed circumferentially around the longitudinal axis; aplurality of prosthetic leaflets, coupled to the frame, disposed withinthe lumen, and arranged to provide unidirectional flow of blood from anupstream end of the lumen to a downstream end of the lumen; an outerframe: including a ring defined by a pattern of alternating peaks andtroughs, the peaks being longitudinally closer to the upstream end thanto the downstream end, and the troughs being longitudinally closer tothe downstream end than to the upstream end, and the pattern of the ringhaving an amplitude longitudinally between the peaks and the troughs,including a plurality of legs, each of the legs coupled to the ring at arespective trough, and shaped to define a plurality of outer-framecoupling elements, each of the outer-frame coupling elements (i) coupledto the ring at a respective peak, and (ii) fixed with respect to arespective valve-frame coupling element, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the outer-frame coupling elements with respect to thevalve-frame coupling elements is such that compression of the tubularportion from the expanded state toward the compressed state (i) pullsthe outer-frame coupling elements radially inward via radially-inwardpulling of the valve-frame coupling elements on the outer-frame couplingelements, (ii) reduces a circumferential distance between each of theouter-frame coupling elements and its adjacent outer-frame couplingelements, and (iii) increases the amplitude of the pattern of the ring,without increasing a radial gap between the valve frame and the ring bymore than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

There is further provided, in accordance with an embodiment of thepresent invention, an apparatus for use with a native valve that isdisposed between an atrium and a ventricle of a heart of a subject isprovided, the apparatus including: a valve frame, including a tubularportion that circumscribes a longitudinal axis of the valve frame so asto define a lumen along the axis; a plurality of prosthetic leaflets,coupled to the frame, disposed within the lumen, and arranged to provideunidirectional flow of blood from an upstream end of the lumen to adownstream end of the lumen; an outer frame, including: a ring definedby a pattern of alternating peaks and troughs: the peaks beinglongitudinally closer than the troughs to the upstream end, the peaksbeing fixed to respective sites of the tubular portion at respectivecoupling points disposed circumferentially around the longitudinal axis,and the pattern of the ring having an amplitude longitudinally betweenthe peaks and the troughs; and a plurality of legs, each of the legscoupled to the ring at a respective trough, and: the tubular portion has(i) a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and thefixation of the peaks to the respective sites of the tubular portion issuch that compression of the tubular portion from the expanded statetoward the compressed state (i) pulls the peaks radially inward viaradially-inward pulling of the respective sites of the tubular portionon the peaks, (ii) reduces a circumferential distance between each ofthe coupling points and its adjacent coupling points, and (iii)increases the amplitude of the pattern of the ring, without increasing aradial gap between the valve frame and the ring by more than 1.5 mm.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end, a downstream end, and defining aplurality of valve-frame coupling elements disposed circumferentiallyaround the longitudinal axis between the upstream end and the downstreamend but not at the upstream end nor at the downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frame:including a ring defined by a pattern of alternating peaks and troughs,the peaks being longitudinally closer to the upstream end than to thedownstream end, and the troughs being longitudinally closer to thedownstream end than to the upstream end, including a plurality of legs,each of the legs coupled to the ring at a respective trough, and shapedto define a plurality of outer-frame coupling elements, each of theouter-frame coupling elements (i) coupled to the ring at a respectivepeak, and (ii) fixed with respect to a respective valve-frame couplingelement at a respective coupling point, and: the tubular portion has (i)a compressed state in which the tubular portion has a compresseddiameter, and (ii) an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, andexpansion of the tubular portion from the compressed state toward theexpanded state (i) increases a circumferential distance between each ofthe outer-frame coupling elements and its adjacent outer-frame couplingelements, and (ii) moves the plurality of legs in a longitudinallyupstream direction with respect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the outer-frame coupling elements to the respectivevalve-frame coupling elements.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a valveframe, including a tubular portion that circumscribes a longitudinalaxis of the valve frame so as to define a lumen along the axis, thetubular portion having an upstream end and a downstream end; a pluralityof prosthetic leaflets, disposed within the lumen, and arranged toprovide unidirectional flow of blood through the lumen; an outer frame,including: a ring defined by a pattern of alternating peaks and troughs:the peaks being longitudinally closer than the troughs to the upstreamend, the peaks being fixed to respective sites of the tubular portion atrespective coupling points disposed circumferentially around thelongitudinal axis between the upstream end and the downstream end butnot at the upstream end nor the downstream end; and a plurality of legs,each of the legs coupled to the ring at a respective trough, and: thetubular portion has (i) a compressed state in which the tubular portionhas a compressed diameter, and (ii) an expanded state in which thetubular portion has an expanded diameter that is greater than thecompressed diameter, and expansion of the tubular portion from thecompressed state toward the expanded state (i) increases acircumferential distance between each of the coupling points and itsadjacent coupling points, and (ii) moves the plurality of legs in alongitudinally upstream direction with respect to the tubular portion.

In an embodiment, the outer frame may be coupled to the valve frame onlyvia the fixation of the peaks to the respective sites of the tubularportion at the respective coupling points.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including: a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: a valve frame, including: a tubular portion having anupstream end and a downstream end, and shaped to define a lumentherebetween, and an upstream support portion, extending from theupstream end of the tubular portion; and at least one leg, coupled tothe valve frame at a coupling point, and having a tissue-engagingflange; and a valve member disposed within the lumen, and configured tofacilitate one-way liquid flow through the lumen from the upstream endof the tubular portion to the downstream end of the tubular portion, andthe frame assembly: has a compressed state, for percutaneous delivery tothe heart, in which the tubular portion has a compressed diameter, isbiased to assume an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and isconfigured such that increasing the diameter of the tubular portiontoward the expanded diameter causes longitudinal movement: of theupstream support portion toward the coupling point, and of thetissue-engaging flange away from the coupling point.

In an embodiment: the apparatus includes an implant that includes theframe assembly and the valve member, and the apparatus further includesa tool: including a delivery capsule dimensioned (i) to house and retainthe implant in the compressed state, and (ii) to be advancedpercutaneously to the heart of the subject while the implant is housedand in the compressed state, and operable from outside the subject tofacilitate an increase of the diameter of the tubular portion from thecompressed diameter toward the expanded diameter such that the increaseof the diameter actuates longitudinal movement: of the upstream supportportion toward the coupling point, and of the tissue-engaging flangeaway from the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes longitudinal movement of theupstream end of the tubular portion toward the coupling point.

In an embodiment, the coupling point is disposed closer to thedownstream end of the frame assembly than are either the tissue-engagingflange or the upstream support portion.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis.

In an embodiment, the expanded state of the frame assembly may be afully-expanded state of the frame assembly, the leg is expandable intoan expanded state of the leg, independently of increasing the diameterof the tubular portion, and in the expanded state of the leg, the legextends away from the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, the legextends away from the central longitudinal axis, and in the compressedstate of the frame assembly, the leg is generally parallel with thecentral longitudinal axis.

In an embodiment, the frame assembly may be configured such that thelongitudinal movement of the tissue-engaging flange away from thecoupling point is a translational movement of the tissue-engaging flangethat does not include rotation of the tissue-engaging flange.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the tissue-engaging flange away from the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state causes 1-20 mm of longitudinalmovement of the upstream support portion toward the coupling point.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state reduces a distance between theupstream support portion and the tissue-engaging flange by 5-30 mm.

In an embodiment, the frame assembly may be configured such thatincreasing the diameter of the tubular portion by expanding the frameassembly toward the expanded state moves the tissue-engaging flangelongitudinally past the upstream support portion.

In an embodiment, the tubular portion may be defined by a plurality ofcells of the valve frame, and increasing the diameter of the tubularportion by expanding the frame assembly toward the expanded state:includes (i) increasing a width, orthogonal to the longitudinal axis ofthe frame assembly, of each cell, and (ii) reducing a height, parallelwith the longitudinal axis of the frame assembly, of each cell, andcauses longitudinal movement of the upstream support portion toward thecoupling point by reducing a height, parallel with the longitudinal axisof the frame assembly, of the tubular portion, by reducing the height ofeach cell.

In an embodiment, the leg is disposed on an outside of the tubularportion.

In an embodiment, the at least one leg includes a plurality of legs, thecoupling point includes a plurality of coupling points, and the frameassembly includes a leg frame that circumscribes the tubular portion,includes the plurality of legs, and is coupled to the valve frame at theplurality of coupling points, such that the plurality of legs isdistributed circumferentially around the tubular portion.

In an embodiment, the plurality of coupling points is disposedcircumferentially around the frame assembly on a transverse plane thatis orthogonal to the longitudinal axis of the frame assembly.

In an embodiment, the plurality of legs may be coupled to the valveframe via a plurality of struts, each strut having a first end that iscoupled to a leg of the plurality of legs, and a second end that iscoupled to a coupling point of the plurality of coupling points, in thecompressed state of the frame assembly, being disposed at a first anglein which the first end is disposed closer to the downstream end of theframe assembly than is the second end, and being deflectable withrespect to the coupling point of the plurality of coupling points, suchthat increasing the diameter of the tubular portion by expanding theframe assembly toward the expanded state causes the strut to deflect toa second angle in which the first end is disposed further from thedownstream end of the frame assembly than is the first end in thecompressed state of the frame assembly.

In an embodiment, the leg frame may be structured such that each leg ofthe plurality of legs is coupled to two struts of the plurality ofstruts, and two struts of the plurality of struts are coupled to eachcoupling point of the plurality of coupling points.

In an embodiment, the leg may be coupled to the valve frame via a strut,the strut having a first end that is coupled to the leg, and a secondend that is coupled to the coupling point, in the compressed state ofthe frame assembly, being disposed at a first angle in which the firstend is disposed closer to the downstream end of the frame assembly thanis the second end, and being deflectable with respect to the couplingpoint, such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causes the strutto deflect to a second angle in which the first end is disposed furtherfrom the downstream end of the frame assembly than is the first end inthe compressed state of the frame assembly.

In an embodiment, the at least one leg includes at least a first leg anda second leg.

In an embodiment, the first leg and the second leg are both coupled tothe valve frame at the coupling point.

In an embodiment, the first leg may be coupled to the coupling point viaa respective first strut, and the second leg is coupled to the couplingpoint via a respective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly: the coupling point is disposed,circumferentially with respect to the tubular portion, between the firststrut and the second strut, the first strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the first leg, and the second strut is disposed,circumferentially with respect to the tubular portion, between thecoupling point and the second leg.

In an embodiment, the coupling point includes at least a first couplingpoint and a second coupling point.

In an embodiment, the leg is coupled to the valve frame at the firstcoupling point and at the second coupling point.

In an embodiment, the leg may be coupled to the first coupling point viaa respective first strut, and to the second coupling point via arespective second strut.

In an embodiment, the first and second legs, the first and secondstruts, and the coupling point are arranged such that, in the expandedstate of the frame assembly: the leg is disposed, circumferentially withrespect to the tubular portion, between the first strut and the secondstrut, the first strut is disposed, circumferentially with respect tothe tubular portion, between the leg and the first coupling point, andthe second strut is disposed, circumferentially with respect to thetubular portion, between the leg and the second coupling point.

In an embodiment, in the expanded state of the frame assembly, theupstream support portion extends radially outward from the tubularportion.

In an embodiment, the expanded state of the frame assembly is afully-expanded state of the frame assembly, the upstream support portionis expandable into an expanded state of the upstream support portion,independently of increasing the diameter of the tubular portion, and inthe expanded state of the upstream support portion, the upstream supportportion extends radially outward from the tubular portion.

In an embodiment, in the compressed state of the frame assembly, theupstream support portion is generally tubular, collinear with thetubular portion, and disposed around the central longitudinal axis.

In an embodiment, in the expanded state of the frame assembly, an innerregion of the upstream support portion extends radially outward from thetubular portion at a first angle with respect to the tubular portion,and an outer region of the upstream support portion extends, from theinner region of the upstream support portion, further radially outwardfrom the tubular portion at a second angle with respect to the tubularportion, the second angle being smaller than the first angle.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: a valve frame, including: a tubular portion having anupstream end and a downstream end, and shaped to define a lumentherebetween, and an upstream support portion, extending from theupstream end of the tubular portion; and at least one leg, coupled tothe valve frame at a coupling point, and having a tissue-engagingflange; and a valve member disposed within the lumen, and configured tofacilitate one-way liquid flow through the lumen from the upstream endof the tubular portion to the downstream end of the tubular portion, andthe frame assembly: has a compressed state, for percutaneous delivery tothe heart, in which the tubular portion has a compressed diameter, isbiased to assume an expanded state in which the tubular portion has anexpanded diameter that is greater than the compressed diameter, and isconfigured such that reducing the diameter of the tubular portion towardthe compressed diameter causes longitudinal movement of the upstreamsupport portion away from the coupling point, and of the tissue-engagingflange toward the coupling point.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, including:a valve frame, including: a tubular portion having an upstream end and adownstream end, and shaped to define a lumen therebetween, and anupstream support portion, extending from the upstream end of the tubularportion; and at least one leg, coupled to the valve frame at a couplingpoint, and having a tissue-engaging flange; and a valve member disposedwithin the lumen, and configured to facilitate one-way liquid flowthrough the lumen from the upstream end of the tubular portion to thedownstream end of the tubular portion, and the frame assembly: has acompressed state, for percutaneous delivery to the heart, isintracorporeally expandable into an expanded state in which a diameterof the tubular portion is greater than in the compressed state, and isconfigured such that increasing the diameter of the tubular portion byexpanding the frame assembly toward the expanded state causeslongitudinal movement of the tissue-engaging flange away from thecoupling point.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve of a heart of a subject is provided, theapparatus including a frame assembly, having an upstream end and adownstream end, and a central longitudinal axis therebetween, andincluding: an inner frame including an inner-frame tubular portion thatcircumscribes the central longitudinal axis, has an upstream end and adownstream end, and defines a channel therebetween, the inner framedefining a plurality of inner-frame couplings disposed circumferentiallyat a longitudinal location of the inner frame, an outer frame includingan outer-frame tubular portion that coaxially circumscribes at least aportion of the inner-frame tubular portion, the outer frame defining aplurality of outer-frame couplings disposed circumferentially at alongitudinal location of the outer frame, and a plurality of connectors,each connector connecting a respective inner-frame coupling to arespective outer-frame coupling; a liner, disposed over at least part ofthe inner-frame tubular portion; and a plurality of prosthetic leaflets,coupled to the inner-frame tubular portion and disposed within thechannel, and: the frame assembly: (i) is compressible by aradially-compressive force into a compressed state in which the innerframe is in a compressed state thereof and the outer frame is in acompressed state thereof, (ii) is configured, upon removal of theradially-compressive force, to automatically expand into an expandedstate thereof in which the inner frame is in an expanded state thereofand the outer frame is in an expanded state thereof, in the expandedstate of the frame assembly, the prosthetic leaflets are configured tofacilitate one-way fluid flow, in a downstream direction, through thechannel, and the connection of the inner-frame couplings to therespective outer-frame couplings is such that expansion of the frameassembly from the compressed state to the expanded state causes theinner-frame tubular portion to slide longitudinally in a downstreamdirection with respect to the outer-frame tubular portion.

In accordance with an embodiment of the present invention, an apparatusfor use with a native valve disposed between an atrium and a ventricleof a heart of a subject is provided, the apparatus including: a tubularportion, having an upstream portion that includes an upstream end, and adownstream portion that includes a downstream end, and shaped to definea lumen between the upstream portion and the downstream portion; aplurality of prosthetic leaflets, disposed within the lumen, andarranged to provide unidirectional flow of blood from the upstreamportion to the downstream portion; an annular upstream support portion:having an inner portion that extends radially outward from the upstreamportion, and including one or more fabric pockets disposedcircumferentially around the inner portion, each pocket of the one ormore pockets having an opening that faces a downstream direction.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, at the inner portion of the upstream supportportion, the covering is closely-fitted between the radially-inner partsof the arms, and at the outer portion of the upstream support portion,the pockets are formed by the covering being loosely-fitted between theradially-outer parts of the arms.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, the radially-outer part being more flexiblethan the radially-inner part.

In an embodiment, the upstream support portion includes (i) a pluralityof arms that extend radially outward from the tubular portion, and (ii)a covering, disposed over the plurality of arms, each arm has (i) aradially-inner part at the inner portion of the upstream supportportion, and (ii) a radially-outer part at the outer portion of theupstream support portion, at the outer portion of the upstream supportportion, the pockets are formed by each arm curving to form a hookshape.

In an embodiment, each pocket may be shaped and arranged to billow inresponse to perivalvular flow of blood in an upstream direction.

In an embodiment, the apparatus may be configured to be transluminallydelivered to the heart and implanted at the native valve by expansion ofthe apparatus, such that the upstream support portion is disposed in theatrium and the tubular portion extends from the upstream support portioninto the ventricle, and each pocket is shaped and arranged such thatperivalvular flow of blood in an upstream direction presses the pocketagainst tissue of the atrium.

In accordance with an embodiment of the present invention, an apparatusis provided including a plurality of prosthetic valve leaflets; and aframe assembly, including: a tubular portion defined by a repeatingpattern of cells, the tubular portion extending circumferentially arounda longitudinal axis so as to define a longitudinal lumen, the prostheticvalve leaflets coupled to the inner frame and disposed within the lumen;an outer frame, including a plurality of legs, distributedcircumferentially around the tubular portion, each leg having atissue-engaging flange; an upstream support portion that includes aplurality of arms that extend radially outward from the tubular portion;and a plurality of appendages, each having a first end that defines acoupling element via which the tubular portion is coupled to the outerframe, and a second end; and the frame assembly defines a plurality ofhubs, distributed circumferentially around the longitudinal axis on aplane that is transverse to the longitudinal axis, each hub defined byconvergence and connection of, (i) two adjacent cells of the tubularportion, (ii) an arm of the plurality of arms, and (iii) an appendage ofthe plurality of appendages.

In an embodiment, each hub has six radiating spokes, two of the sixspokes being part of a first cell of the two adjacent cells, two of thesix spokes being part of a second cell of the two adjacent cells, one ofthe six spokes being the arm, and one of the six spokes being the secondend of the appendage.

In an embodiment, the appendages are in-plane with the tubular portion.

In an embodiment, the appendages are in-plane with the outer frame.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant: including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that a tissue-engaging flange of the leg is disposed downstream ofthe valve, and thereafter causing the flange to protrude radiallyoutward from the axis; subsequently, while an upstream support portionof the valve frame is disposed upstream of the valve, causing theupstream support portion to protrude radially outward from the axis,such that tissue of the valve is disposed between the upstream supportportion and the flange; and subsequently, sandwiching the tissue betweenthe upstream support portion and the flange by reducing a distancebetween the upstream support portion and the flange by causinglongitudinal movement (i) of the upstream support portion toward thecoupling point, and (ii) of the tissue-engaging flange away from thecoupling point.

In an embodiment, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding percutaneously advancing to heart, an implant: including avalve frame, a valve member disposed within a lumen defined by the valveframe, and at least one leg, coupled to the valve frame at a couplingpoint, and having an upstream end, a downstream end, and a centrallongitudinal axis therebetween; positioning the implant within the heartsuch that an upstream support portion of the valve frame is disposedupstream of the valve, and thereafter causing the upstream supportportion to protrude radially outward from the axis; subsequently, whilea tissue-engaging flange of the leg is disposed downstream of the valve,causing the tissue-engaging flange to protrude radially outward from theaxis, such that tissue of the valve is disposed between the upstreamsupport portion and the flange; and subsequently, sandwiching the tissuebetween the upstream support portion and the flange by reducing adistance between the upstream support portion and the flange by causinglongitudinal movement (i) of the upstream support portion toward thecoupling point, and (ii) of the tissue-engaging flange away from thecoupling point.

In an embodiment, causing the longitudinal movement (i) of the upstreamsupport portion toward the coupling point, and (ii) of thetissue-engaging flange away from the coupling point, includes causingthe longitudinal movement by increasing a diameter of the lumen.

In accordance with an embodiment of the present invention, a method foruse with a native valve of a heart of a subject is provided, the methodincluding: percutaneously advancing an implant to the heart, the implanthaving an upstream end, a downstream end, and a central longitudinalaxis therebetween, and including a tubular portion, an upstream supportportion, and a plurality of tissue-engaging flanges; positioning theimplant within the heart such that the upstream support portion isdisposed upstream of the valve, positioning the implant within the heartsuch that the tissue-engaging flanges are disposed downstream of thevalve, without increasing a diameter of the tubular portion: causing theupstream support portion to extend radially outward from the axis so asto have a first support-portion span, and causing the flanges to extendradially outward from the axis so as to have a first flange span; andsubsequently, causing the upstream support portion and the flanges movetoward each other by at least 5 mm by increasing a diameter of thetubular portion such that: the upstream support portion extends radiallyoutward so as to have a second support-portion span, the firstsupport-portion span being at least 40 percent as great as the secondsupport-portion span, and the flanges extend radially outward so as tohave a second flange span, the first flange span being at least 30percent as great as the second flange span.

There is further provided, in accordance with an application of thepresent invention, a method for use with a native valve of a heart of asubject, the method including: percutaneously advancing an implant tothe heart, the implant: having an upstream end, a downstream end, and acentral longitudinal axis therebetween, and including a tubular portion,an upstream support portion, and a plurality of tissue-engaging flanges;positioning the implant within the heart such that the upstream supportportion is disposed upstream of the valve, positioning the implantwithin the heart such that the tissue-engaging flanges are disposeddownstream of the valve, without increasing a diameter of the tubularportion: causing the upstream support portion to extend radially outwardfrom the axis, and causing the flanges to extend radially outward fromthe axis so as to have a first flange span; and subsequently, byincreasing a diameter of the tubular portion: causing the upstreamsupport portion and the flanges move toward each other by at least 5 mm,causing the upstream support portion to move further radially outwardfrom the axis, and causing each flange of the plurality of flanges totranslate radially outward so as to have a second flange span that isgreater than the first flange span.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B and 2A-E are schematic illustrations of an implant for usewith a native valve of a heart of a subject, in accordance with someapplications of the invention;

FIGS. 3A-C are schematic illustrations that show structural changes in aframe assembly during transitioning of the assembly between itscompressed and expanded states, in accordance with some applications ofthe invention;

FIGS. 4A-F are schematic illustrations of implantation of the implant atthe native valve, in accordance with some applications of the invention;

FIG. 5 is a schematic illustration of a step in the implantation of theimplant, in accordance with some applications of the invention;

FIG. 6 is a schematic illustration of the implant, in accordance withsome applications of the invention;

FIGS. 7A-B and 8A-B are schematic illustrations of frame assemblies ofrespective implants, in accordance with some applications of theinvention; and

FIGS. 9A-C are schematic illustrations of an implant including a frameassembly, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-B and 2A-E, which are schematicillustrations of an implant 20 (alternatively, “prosthetic valve 20”)for use with a native valve of a heart of a subject, in accordance withsome embodiments of the invention. Prosthetic valve 20 includes a frameassembly 22 that has an upstream end 24 (alternatively, “atrial end24”), a downstream end 26 (alternatively, “ventricular end 26”), and acentral longitudinal axis ax1 therebetween. The term “atrial end” mayrefer to an end of a given feature which is configured to be situatedclosest to an atrium of the heart when prosthetic valve 20 is implantedtherein. For example, in FIGS. 1A, 1B, and 2A-2E, the atrial end ofprosthetic valve 20 may be the top end of prosthetic valve 20.Similarly, the term “ventricular end” may refer to an end of a givenfeature which is configured to be situated closest to a ventricle of theheart when prosthetic valve 20 is implanted therein. For example, inFIGS. 1A, 1B, and 2A-2E, the ventricular end of prosthetic valve 20 maybe the bottom end of prosthetic valve 20. Frame assembly 22 may includea valve frame 30 (alternatively, “inner frame 30”) that includes atubular portion 32 (alternatively, “inner frame tubular portion 32”)that has an upstream end 34 (alternatively, “atrial end 34”) and adownstream end 36 (alternatively, “ventricular end 36”), and is shapedto define a lumen 38 through the inner frame tubular portion 32 from theatrial end to the ventricular end. Inner frame tubular portion 32circumscribes axis ax1, and thereby defines lumen 38 along the axis.Inner frame 30 further includes an upstream support portion 40,extending from atrial end 34 of inner frame tubular portion 32. Frameassembly 22 further includes at least one leg 50 (alternatively,“ventricular anchor support 50”), coupled to inner frame 30 at (e.g.,via) a coupling point 52, and having a tissue-engaging flange 54(alternatively, “ventricular anchoring leg 54”). As illustrated in FIG.1B, ventricular anchoring legs 54 may extend from outer frame 60.

In some embodiments, and as described hereinbelow, ventricular anchorsupport 50 is part of an outer frame 60, and frames 30 and 60 definerespective coupling elements 31 and 61, which are fixed with respect toeach other at coupling points 52. As illustrated in FIG. 1A, inner frame30 may be positioned at least partially within outer frame 60. In someembodiments, frames 30 and 60 are coupled to each other only at couplingpoints 52 (e.g., only via the fixation of coupling elements 31 and 61with respect to each other).

Prosthetic valve 20 further includes a valve member 58 (e.g., one ormore prosthetic leaflets) disposed within lumen 38, and configured tofacilitate one-way liquid flow through the lumen from atrial end 34 toventricular end 36 (e.g., thereby defining the orientation of the atrialand ventricular ends of inner frame tubular portion 32). FIG. 1A showsprosthetic valve 20 in a fully-expanded state, in which frame assembly22 is in a fully-expanded state. FIG. 1B shows an exploded view of frameassembly 22 in its fully-expanded state. FIGS. 2A-E show respectiveconfigurations of prosthetic valve 20, which will be discussed in moredetail hereinbelow with respect to the implantation of the prostheticvalve and the anatomy in which the prosthetic valve is implanted. FIG.2A shows prosthetic valve 20 in a compressed state in which frameassembly 22 is in a compressed state for percutaneous delivery of theprosthetic valve to the heart of the subject. As illustrated in FIGS. 4Aand 4B, frame assembly 22 may be in the compressed state when it isconstrained within delivery device 89 during delivery to the heart;thus, the compressed state of frame assembly 22 illustrated in FIG. 2Amay also constitute a delivery configuration of the frame assembly 22.In some embodiments, in the delivery configuration, ventricular anchorsupport 50 (including ventricular anchoring leg 54 thereof) is in aradially constrained state in which the ventricular anchoring leg isgenerally parallel with axis ax1. For example, ventricular anchorsupport 50 (including ventricular anchoring leg 54) may be in thedelivery configuration and extending in an upstream direction towardsatrium 6 when radially constrained within delivery device 89, asillustrated in FIG. 4A. Further in some embodiments, in the deliveryconfiguration, upstream support portion 40 (including atrial anchoringarms 46) is generally tubular, collinear with inner frame tubularportion 32 (e.g., extending collinearly from the inner frame tubularportion), and disposed around axis ax1. For example, upstream supportportion 40 may be in the delivery configuration when radiallyconstrained within delivery device 89, as illustrated in FIG. 4A.

FIG. 2B shows a state of prosthetic valve 20 in which ventricularanchoring leg 54 of each ventricular anchor support 50 extends radiallyaway from axis ax1 (e.g., radially away from inner frame tubular portion32) in a deployed configuration. FIG. 2C shows a state of prostheticvalve 20 in which upstream-support portion 40 (including atrialanchoring arms 46) extends radially away from axis ax1 (and therebyradially away from inner frame tubular portion 32) in a deployedconfiguration. FIG. 2D shows a state of prosthetic valve 20 in whichboth ventricular anchoring leg 54 and portion 40 extend away from axisax1 in their respective deployed configurations. In the fully-expandedstate (FIGS. 1A-B) (that is, a deployed configuration of frame assembly22), both upstream support portion 40 and ventricular anchoring leg 54extend radially away from axis ax1. In some embodiments, frame assembly22 is biased (e.g., shape-set) to assume its deployed configuration,which is shown in FIG. 2E. Transitioning of prosthetic valve 20 betweenthe respective configurations may be controlled by a delivery apparatus,such as by constraining the prosthetic valve in a delivery configurationwithin a delivery tube and/or against a control rod, and selectivelyreleasing portions of the prosthetic valve to allow them to expand.

In some embodiments, as depicted in FIGS. 2A and 2B, for example, atleast one ventricular anchoring leg 54 may be configured such that itsentire length may extend in an atrial direction or, alternatively, in anon-ventricular direction, in both the delivery configuration and thedeployed configuration. With reference to FIG. 3A, the term “entirelength” of a ventricular anchoring leg 54 may refer to the lengthextending from junction 75 (which is a point of intersection between leg54 and connectors 78) to the terminal end of ventricular anchoring leg54. The term “atrial direction” may refer to a direction extendingupstream from prosthetic valve 20, towards an atrium of the heart. Forexample, in FIGS. 4A-4E, an “atrial direction” may refer to a directionextending upstream from the valve towards left atrium 6. The term“ventricular direction” may refer to a direction extending downstreamfrom prosthetic valve 20, towards a ventricle of the heart. Thus, theterm “non-ventricular direction” may refer to any direction which doesnot extend towards a ventricle of the heart; a “non-ventriculardirection” may extend in an atrial direction, or it may extend laterallyin a direction perpendicular to the ventricular direction. In someembodiments, an “atrial direction” may be angled radially inward oroutward from prosthetic valve 20, so long as it also is angled upstream(towards an atrium) and not downstream (towards a ventricle); that is,an “atrial direction” need not necessarily be parallel to longitudinalaxis ax1, although it may be parallel to longitudinal axis ax1 in someembodiments. Similarly, a “ventricular direction” may be angled radiallyinward or outward from prosthetic valve 20, so long as it also is angleddownstream, towards a ventricle. For example, in FIGS. 4A-4F, a“ventricular direction” may refer to a direction extending downstream(downwards in FIGS. 4A-4F) from the valve towards the left ventricle. A“ventricular direction” need not necessarily be parallel to longitudinalaxis ax1, although it may be parallel to longitudinal axis ax1 in someembodiments.

In the delivery configuration of frame assembly 22, inner frame tubularportion 32 has a diameter d1, and in the deployed configuration, theinner frame tubular portion has a diameter d2 that is greater thatdiameter d1. For some embodiments, diameter d1 is 4-15 mm, (e.g., 5-11mm) and diameter d2 is 20-50 mm, (e.g., 23-33 mm). Frame assembly 22 isconfigured such that increasing the diameter of inner frame tubularportion 32 (e.g., from d1 to d2) causes longitudinal movement ofventricular anchoring leg 54 away from coupling point 52. In the sameway, reducing the diameter of inner frame tubular portion 32 (e.g., fromd2 to d1) causes longitudinal movement of ventricular anchoring leg 54toward coupling point 52. It is to be noted that the term “longitudinalmovement” (including the specification and the claims) means movementparallel with central longitudinal axis ax1. Therefore longitudinalmovement of ventricular anchoring leg 54 away from coupling point 52means increasing a distance, measured parallel with longitudinal axisax1, between ventricular anchoring leg 54 and coupling point 52. Anexample of such a configuration is described in more detail with respectto FIG. 3A.

Thus, expansion of inner frame tubular portion 32 from its deliveryconfiguration toward its deployed configuration increases acircumferential distance between each of coupling points 52 and itsadjacent coupling points (e.g., between each of outer-frame couplingelements 61 and its adjacent outer-frame coupling elements) (e.g., fromd8 to d9), and moves ventricular anchor supports 50 in a longitudinallyupstream direction with respect to the inner frame tubular portion.According to some embodiments, such as the embodiments depicted in FIGS.1B and 3A, because a circumferential distance between adjacent couplingpoints 52 may be equal for all coupling points 52 (e.g., d8 or d9), acircumferential distance between adjacent ventricular anchoring legs 54may also be equal for all legs, since each leg is disposed between twoadjacent coupling points 52. Thus, ventricular anchoring legs 54 may bespaced at a regular interval about a circumference of outer frame 60 anda circumference of annular valve body 25 (described further below).

In some embodiments, frame assembly 22 is configured such thatincreasing the diameter of inner frame tubular portion 32 also causeslongitudinal movement of upstream support portion 40 toward couplingpoint 52, e.g., as described in more detail with respect to FIGS. 3B-C.In some embodiments, frame assembly 22 is configured such thatincreasing the diameter of inner frame tubular portion 32 also causeslongitudinal movement of atrial end 34 of inner frame tubular portion 32toward coupling point 52. In the same way, reducing the diameter ofinner frame tubular portion 32 causes longitudinal movement of atrialend 34 away from coupling point 52.

For some embodiments, upstream support portion 40 includes a pluralityof atrial anchoring arms 46 that each extends radially outward frominner frame tubular portion 32 (e.g., from atrial end 34 of the innerframe tubular portion). Atrial anchoring arms 46 may be flexible. Forsome such embodiments, atrial anchoring arms 46 are coupled to innerframe tubular portion 32 such that each atrial anchoring arm may deflectindependently of adjacent atrial anchoring arms during implantation(e.g., due to anatomical topography).

For some embodiments, upstream support portion 40 includes a pluralityof barbs 48 that extend out of a downstream surface of the upstreamsupport portion. For example, each atrial anchoring arm 46 may includeone or more of barbs 48. Barbs 48 press into tissue upstream of thenative valve (e.g., into the valve annulus), thereby inhibitingdownstream movement of prosthetic valve 20 (in addition to inhibition ofdownstream movement provided by the geometry of upstream support portion40).

One or more surfaces of frame assembly 22 are covered with a covering23, which in some embodiments includes a flexible sheet, such as afabric, e.g., including polyester. In some embodiments, covering 23covers at least part of inner frame tubular portion 32, in someembodiments lining an inner surface of the inner frame tubular portion,and thereby defining lumen 38.

Further in some embodiments, upstream support portion 40 is covered withcovering 23, e.g., extending between atrial anchoring arms 46 to form anannular shape. It is hypothesized that this reduces a likelihood ofparavalvular leakage. For such embodiments, excess covering 23 may beprovided between atrial anchoring arms 46 of upstream support portion40, so as to facilitate their independent movement. Although FIG. 1Ashows covering 23 covering an upstream side of upstream support portion40, the covering may additionally or alternatively cover the downstreamside of the upstream support portion. For example, covering 23 mayextend over the tips of atrial anchoring arms 46 and down the outside ofthe arms, or a separate piece of covering may be provided on thedownstream side of the upstream support portion.

Alternatively, each atrial anchoring arm 46 may be individually coveredin a sleeve of covering 23, thereby facilitating independent movement ofthe atrial anchoring arms.

For some embodiments, at least part of ventricular anchor supports 50(e.g., ventricular anchoring legs thereof) is covered with covering 23.

In some embodiments, frame assembly 22 includes a plurality ofventricular anchor supports 50 (e.g., two or more ventricular anchorsupports, e.g., 2-16 ventricular anchor supports, such as 4-12ventricular anchor supports, such as 6-12 ventricular anchor supports),arranged circumferentially around inner frame 30 (e.g., around theoutside of inner frame tubular portion 32). In some embodiments, frameassembly 22 includes a plurality of coupling points 52 at which theventricular anchor supports are coupled to inner frame 30.

As described in more detail hereinbelow (e.g., with reference to FIG.3A), each ventricular anchor support 50 may be coupled to a couplingpoint 52 via a strut 70. For some embodiments, each ventricular anchorsupport 50 is coupled to a plurality of (e.g., two) coupling points 52via a respective plurality of (e.g., two) struts 70. For some suchembodiments, frame assembly 22 is arranged such that, in the deployedconfiguration of the frame assembly, ventricular anchor support 50 isdisposed, circumferentially with respect to inner frame tubular portion32, between two struts, and each of the two struts are disposed,circumferentially with respect to the inner frame tubular portion,between the ventricular anchor support 50 and a respective couplingpoint 52.

For some embodiments, a plurality of (e.g., two) ventricular anchorsupports are coupled to each coupling point 52 via a respectiveplurality of (e.g., two) struts 70. For some such embodiments, frameassembly 22 is arranged such that, in the deployed configuration of theframe assembly, coupling point 52 is disposed, circumferentially withrespect to inner frame tubular portion 32, between two struts 70, andeach of the two struts are disposed, circumferentially with respect tothe inner frame tubular portion, between the coupling point and arespective ventricular anchor support 50.

For some embodiments, frame assembly 22 includes an outer frame 60 thatcircumscribes inner frame tubular portion 32, includes (or defines) theplurality of ventricular anchor supports 50 and the plurality of struts70, and is coupled to inner frame 30 at the plurality of coupling points52, such that the plurality of ventricular anchor supports aredistributed circumferentially around the inner frame tubular portion.For such embodiments, outer frame 60 includes a ring 66 that is definedby a pattern of alternating peaks 64 and troughs 62, and that in someembodiments circumscribes inner frame tubular portion 32. For example,the ring may include struts 70, extending between the peaks and troughs.Peaks 64 are longitudinally closer to atrial end 34 of inner frametubular portion 32 than to ventricular end 36, and troughs 62 arelongitudinally closer to the ventricular end than to the atrial end. (Itis to be noted that throughout this patent application, including thespecification and the claims, the term “longitudinally” means withrespect to longitudinal axis ax1. For example, “longitudinally closer”means closer along axis ax1 (whether positioned on axis ax1 or lateralto axis ax1), and “longitudinal movement” means a change in positionalong axis ax1 (which may be in additional to movement toward or awayfrom axis ax1). Therefore, peaks 64 are closer than troughs 62 to atrialend 34, and troughs 62 are closer than peaks 64 to ventricular end 36.As illustrated in FIG. 1B, outer frame 60 may include multiple rings 66;in embodiments depicted in FIG. 1B, outer frame 60 includes two rings 66connected by ventricular anchoring supports 50. Rings 66 and ventricularanchor supports 50 may form an annular outer frame tubular portion 65.Outer frame tubular portion 65 may have an atrial end 67 and aventricular end 69, and may circumscribe axis ax1. In some embodiments,atrial end 67 may constitute a portion of the most upstream ring 66 andventricular end 69 may constitute a portion of the most downstream ring66. As also illustrated in FIG. 1B, ventricular anchoring legs 54 mayextend from outer frame tubular portion 65. For embodiments in whichframe 60 includes ring 66, each ventricular anchor support 50 is coupledto the ring (or defined by frame 60) at a respective trough 62.

In the embodiment shown, the peaks and troughs are defined by ring 66having a generally zig-zag shape. However, the scope of the inventionincludes ring 66 having another shape that defines peaks and troughs,such as a serpentine or sinusoid shape.

In some embodiments, inner frame tubular portion 32 and outer frametubular portion 65 may form annular valve body 25. Annular valve body 25may circumscribe axis ax1, and atrial anchoring arms 46 and ventricularanchoring legs 54 may extend from annular valve body 25. Annular valvebody 25 may have an upstream end (alternatively, an “atrial end”), adownstream end (alternatively, a “ventricular end”), and an intermediateportion extending between the atrial end and the ventricular end. Forexample, in embodiments depicted in FIG. 1A, atrial end 34 andventricular end 36 of inner frame tubular portion 32 may constitute theatrial and ventricular ends of annular valve body 25, respectively.According to such embodiments, the intermediate portion of annular valvebody 25 may include portions of annular valve body 25 positioned betweenatrial end 34 and ventricular end 36. However, one of ordinary skillwill understand that this embodiment is merely exemplary, and that otherportions of annular valve body 25 may form the atrial and ventricularends of annular valve body 25.

For embodiments in which frame assembly 22 has a plurality of couplingpoints 52, the coupling points (and therefore coupling elements 31 and61) are disposed circumferentially around the frame assembly (e.g.,around axis ax1), in some embodiments on a transverse plane that isorthogonal to axis ax1. This transverse plane is illustrated by theposition of section A-A in FIG. 2B. Alternatively, coupling points 52may be disposed at different longitudinal heights of frame assembly 22,e.g., such that different ventricular anchoring legs 54 are positionedand/or moved differently to others. In some embodiments, coupling points52 (and therefore coupling elements 31 and 61) are disposedlongitudinally between atrial end 24 and ventricular end 26 of frameassembly 22, but not at either of these ends. Further in someembodiments, coupling points 52 are disposed longitudinally betweenatrial end 34 and ventricular end 36 of inner frame tubular portion 32,but not at either of these ends. For example, the coupling points may bemore than 3 mm (e.g., 4-10 mm) both from end 34 and from end 36. It ishypothesized that this advantageously positions the coupling points at apart of inner frame tubular portion 32 that is more rigid than end 34 orend 36.

It is to be noted that ventricular anchor support 50 may be expandableinto its deployed configuration (e.g., a released-leg state) such thatventricular anchoring leg 54 extends away from axis ax1, independentlyof increasing the diameter of inner frame tubular portion 32 (e.g., asshown in FIGS. 2B & 2D). Similarly, upstream support portion 40 may beexpandable into its deployed configuration (e.g., a released-arm state)such that it (e.g., atrial anchoring arms 46 thereof) extends away fromaxis ax1, independently of increasing the diameter of inner frametubular portion 32 (e.g., as shown in FIGS. 2C & 2D). The configurationshown in FIG. 2D may be considered to be an intermediate configuration.Therefore, prosthetic valve 20 may be configured such that ventricularanchor supports 50 (e.g., ventricular anchoring legs 54 thereof) andupstream support portion 40 are expandable such that they both extendaway from axis ax1, while retaining a distance d3 therebetween. Thisdistance is subsequently reducible to a distance d4 by expanding innerframe tubular portion 32 (e.g., shown in FIG. 2E).

For some embodiments, while inner frame tubular portion 32 remains inits delivery configuration, ventricular anchoring leg 54 can extend awayfrom axis ax1 over 40 percent (e.g., 40-80 percent, such as 40-70percent) of the distance that it extends from the axis subsequent to theexpansion of the inner frame tubular portion. For example, forembodiments in which prosthetic valve 20 includes a ventricularanchoring leg on opposing sides of the prosthetic valve, a span d15 ofthe ventricular anchoring legs while inner frame tubular portion 32 isin its delivery configuration may be at least 40 percent (e.g., 40-80percent, such as 40-70 percent) as great as a span d16 of theventricular anchoring legs subsequent to the expansion of the innerframe tubular portion. For some embodiments, span d15 is greater than 15mm and/or less than 50 mm (e.g., 20-30 mm). For some embodiments, spand16 is greater than 30 mm and/or less than 60 mm (e.g., 40-50 mm). It isto be noted that ventricular anchoring leg 54 is effectively fullyexpanded, with respect to other portions of ventricular anchor support50 and/or with respect to inner frame tubular portion 32, before andafter the expansion of the inner frame tubular portion.

Similarly, for some embodiments, while inner frame tubular portion 32remains in its delivery configuration, upstream support portion 40(e.g., atrial anchoring arms 46) can extend away from axis ax1 over 30percent (e.g., 30-70 percent) of the distance that it extends from theaxis subsequent to the expansion of the inner frame tubular portion.That is, for some embodiments, a span d17 of the upstream supportportion while inner frame tubular portion 32 is in its deliveryconfiguration may be at least 30 percent (e.g., 30-70 percent) as greatas a span d18 of the upstream support portion subsequent to theexpansion of the inner frame tubular portion. For some embodiments, spand17 is greater than 16 mm (e.g., greater than 20 mm) and/or less than 50mm (e.g., 30-40 mm). For some embodiments, span d18 is greater than 40mm and/or less than 65 mm (e.g., 45-56 mm, such as 45-50 mm). It is tobe noted that upstream support portion 40 is effectively fully expanded,with respect to inner frame tubular portion 32, before and after theexpansion of the inner frame tubular portion.

It is to be noted that when inner frame tubular portion 32 is expanded,ventricular anchoring legs 54 may translate radially outward from spand15 to span d16 (e.g., without deflecting). In some embodiments upstreamsupport portion 40 behaves similarly (e.g., atrial anchoring arms 46translated radially outward from span d17 to span d18, e.g., withoutdeflecting). That is, an orientation of each ventricular anchoring leg54 and/or each atrial anchoring arm 46 with respect to inner frametubular portion 32 and/or axis ax1 may be the same in the configurationshown in FIG. 2D as it is in the configuration shown in FIG. 2E.Similarly, for some embodiments an orientation of each ventricularanchoring leg 54 with respect to upstream support portion 40 (e.g., withrespect to one or more atrial anchoring arms 46 thereof) is the samebefore and after expansion of inner frame tubular portion 32.

For some embodiments, increasing the diameter of inner frame tubularportion 32 from d1 to d2 causes greater than 1 mm and/or less than 20 mm(e.g., 1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement ofventricular anchoring leg 54 away from coupling point 52. For someembodiments, increasing the diameter of inner frame tubular portion 32from d1 to d2 causes greater than 1 mm and/or less than 20 mm (e.g.,1-20 mm, such as 1-10 mm or 5-20 mm) of longitudinal movement ofupstream support portion 40 toward coupling point 52. For someembodiments, distance d3 is 7-30 mm. For some embodiments, distance d4is 0-15 mm (e.g., 2-15 mm). For some embodiments, increasing thediameter of inner frame tubular portion 32 from d1 to d2 reduces thedistance between the upstream support portion and ventricular anchoringlegs 54 by more than 5 mm and/or less than 30 mm, such as 5-30 mm (e.g.,10-30 mm, such as 10-20 mm or 20-30 mm). For some embodiments, thedifference between d3 and d4 is generally equal to the differencebetween d1 and d2. For some embodiments, the difference between d3 andd4 is more than 1.2 and/or less than 3 times (e.g., 1.5-2.5 times, suchas about 2 times) greater than the difference between d1 and d2.

For some embodiments, ventricular anchoring legs 54 curve such that atip of each ventricular anchoring leg is disposed at a shallower anglewith respect to inner region 42 of upstream support portion 40, than areportions of ventricular anchor support 50 that are closer to ventricularend 26 of frame assembly 22. For some such embodiments, a tip of eachventricular anchoring leg may be generally parallel with inner region42. For some such embodiments, while inner frame tubular portion 32 isin its deployed configuration, a tip portion 55 of each ventricularanchoring leg 54 that extends from the tip of the ventricular anchoringleg at least 2 mm along the ventricular anchoring leg, is disposedwithin 2 mm of upstream support portion 40. Thus, for some embodiments,while inner frame tubular portion 32 is in its deployed configuration,for at least 5 percent (e.g., 5-8 percent, or at least 8 percent) ofspan 18 of upstream support portion 40, the upstream support portion isdisposed within 2 mm of a ventricular anchoring leg 54.

For some embodiments, in the absence of any obstruction (such as tissueof the valve or covering 23) between ventricular anchoring leg 54 andupstream support portion 40, increasing the diameter of inner frametubular portion 32 from d1 to d2 causes the ventricular anchoring legand the upstream support portion to move past each other (e.g., theventricular anchoring leg may move between atrial anchoring arms 46 ofthe upstream support portion), such that the ventricular anchoring legis closer to the atrial end of prosthetic valve 20 than is the upstreamsupport portion, e.g., as shown hereinbelow for frame assemblies 122 and222, mutatis mutandis. (For embodiments in which upstream supportportion 40 is covered by covering 23, ventricular anchoring legs 54 maynot pass the covering. For example, in the absence of any obstruction,ventricular anchoring legs 54 may pass between atrial anchoring arms 46,and press directly against covering 23.) It is hypothesized that forsome embodiments this configuration applies greater force to the valvetissue being sandwiched, and thereby further facilitates anchoring ofthe prosthetic valve. That is, for some embodiments, distance d3 issmaller than the sum of distance d5 and a distance d14 (described withreference to FIG. 3C). For some embodiments, increasing the diameter ofinner frame tubular portion 32 from d1 to d2 advantageously causesventricular anchoring legs 54 and upstream support portion 40 to movegreater than 3 mm and/or less than 25 mm (e.g., greater than 5 mm and/orless than 15 mm, e.g., 5-10 mm, such as about 7 mm) with respect to eachother (e.g., toward each other and then past each other).

In some embodiments, in the deployed configuration of frame assembly 22,upstream support portion 40 has an inner region (e.g., an inner ring) 42that extends radially outward at a first angle with respect to axis ax1(and in some embodiments with respect to inner frame tubular portion32), and an outer region (e.g., an outer ring) 44 that extends, from theinner region, further radially outward from the inner frame tubularportion at a second angle with respect to the inner frame tubularportion, the second angle being smaller than the first angle. Forexample, for some embodiments inner region 42 extends radially outwardat an angle alpha_1 of 60-120 degrees (e.g., 70-110 degrees) withrespect to axis ax1 when in the deployed configuration, and outer region44 extends radially outward at an angle alpha_2 of 5-70 degrees (e.g.,10-60 degrees) with respect to axis ax1 when in the deployedconfiguration. As a result, and as illustrated in FIG. 1A, inner region42 may be configured to extend in a ventricular direction and outerregion 44 may be configured to extend in an atrial direction when atrialanchoring arms 46 are in the deployed configuration. As stated above inreference to FIG. 2A, upstream support portion 40, including atrialanchoring arms 46, may be generally tubular and collinear with innerframe tubular portion 32, and thus arranged substantially parallel withaxis ax1, when in the delivery configuration. Thus, inner region 42 maybe configured to deflect radially outward by angle alpha_1 of 60-120degrees when transitioning from the delivery configuration to thedeployed configuration.

In some embodiments, inner region 42 of each atrial anchoring arm 46 maybe configured to deflect radially outward by the same angle with respectto longitudinal axis ax1 and outer region 44 of each atrial anchoringarm may be configured to deflect radially outward by the same angle withrespect to longitudinal axis ax1. As a result, the terminal ends ofatrial anchoring arms 46 may be substantially aligned in a commonlateral plane when the arms 46 are in the deployed configuration, asdepicted in FIGS. 2C and 2D.

It is to be noted that angles alpha_1 and alpha_2 are measured betweenthe respective region support portion 40, and the portion of axis ax1that extends in an upstream direction from the level of frame assembly22 at which the respective region begins to extend radially outward.

For some embodiments in which prosthetic valve 20 is configured to beplaced at an atrioventricular valve (e.g., a mitral valve or a tricuspidvalve) of the subject, region 42 is configured to be placed against theupstream surface of the annulus of the atrioventricular valve, andregion 44 is configured to be placed against the walls of the atriumupstream of the valve.

For some embodiments, outer region 44 is more flexible than inner region42. For example, and as shown, each atrial anchoring arm 46 may have adifferent structure in region 44 than in region 42. It is hypothesizedthat the relative rigidity of region 42 provides resistance againstventricular migration of prosthetic valve 20, while the relativeflexibility of region 44 facilitates conformation of upstream supportportion 40 to the atrial anatomy.

For some embodiments, two or more of atrial anchoring arms 46 areconnected by a connector (not shown), reducing the flexibility, and/orthe independence of movement of the connected atrial anchoring armsrelative to each other. For some embodiments, atrial anchoring arms 46are connected in particular sectors of upstream support portion 40,thereby making these sectors more rigid than sectors in which the atrialanchoring arms are not connected. For example, a relatively rigid sectormay be provided to be placed against the posterior portion of the mitralannulus, and a relatively flexible sector may be provided to be placedagainst the anterior side of the mitral annulus, so as to reduce forcesapplied by upstream support portion 40 on the aortic sinus.

For some embodiments, and as shown, coupling points 52 are disposedcloser to ventricular end 26 of frame assembly 22 than are ventricularanchoring legs 54, or is upstream support portion 40.

As described in more detail with respect to FIGS. 4A-F, the movement ofventricular anchoring leg 54 away from coupling point 52 (and thetypical movement of upstream support portion 40 toward the couplingpoint) facilitates the sandwiching of tissue of the native valve (e.g.,leaflet and/or annulus tissue) between the ventricular anchoring leg andthe upstream support portion, thereby securing prosthetic valve 20 atthe native valve.

In some embodiments, in the delivery configuration of inner frametubular portion 32, a ventricular end of each ventricular anchor support50 is longitudinally closer than valve-frame coupling elements 31 toventricular end 36, and ventricular anchoring leg 54 of each ventricularanchor support is disposed longitudinally closer than the valve-framecoupling elements to atrial end 34. In some embodiments, this is alsothe case in the deployed configuration of inner frame tubular portion32.

FIGS. 3A-C show structural changes in frame assembly 22 duringtransitioning of the assembly between its delivery and deployedconfigurations, in accordance with some embodiments of the invention.FIGS. 3A-C each show a portion of the frame assembly, the structuralchanges thereof being representative of the structural changes thatoccur in other portions of the frame assembly. FIG. 3A shows aventricular anchor support 50 and struts 70 (e.g., a portion of outerframe 60), and illustrates the structural changes that occur aroundouter frame 60. FIG. 3B shows a portion of inner frame 30, andillustrates the structural changes that occur around the inner frame.FIG. 3C shows inner frame 30 as a whole. In each of FIGS. 3A-C,configuration (A) illustrates the structure while frame assembly 22 (andin particular inner frame tubular portion 32) is in its deliveryconfiguration, and configuration (B) illustrates the structure while theframe assembly (and in particular inner frame tubular portion 32) is inits deployed configuration.

FIG. 3A shows structural changes in the coupling of ventricular anchorsupports 50 to coupling point 52 (e.g., structural changes of outerframe 60) during the transitioning of frame assembly 22 (and inparticular inner frame tubular portion 32) between its delivery anddeployed configurations. Each ventricular anchor support 50 is coupledto inner frame 30 via at least one strut 70, which connects theventricular anchor support to coupling point 52. In some embodiments,each ventricular anchor support 50 is coupled to inner frame 30 via aplurality of struts 70. A first end 72 of each strut 70 is coupled toventricular anchor support 50, and a second end 74 of each strut iscoupled to a coupling point 52. As described hereinabove, forembodiments in which frame 60 includes ring 66, each ventricular anchorsupport 50 is coupled to the ring at a respective trough 62. Ring 66 mayinclude struts 70, extending between the peaks and troughs, with eachfirst end 72 at (or close to) a trough 62, and each second end 74 at (orclose to) a peak 64.

In the delivery configuration of frame assembly 22 (and in particular ofinner frame tubular portion 32), each strut 70 is disposed at a firstangle in which first end 72 is disposed closer than second end 74 to theventricular end of the frame assembly. Expansion of frame assembly 22(and in particular of inner frame tubular portion 32) toward itsdeployed configuration causes strut 70 to deflect to a second angle.This deflection moves first end 72 away from the ventricular end offrame assembly 22. That is, in the deployed configuration of frameassembly 22, first end 72 is further from the ventricular end of theframe assembly than it is when the frame assembly is in its deliveryconfiguration. This movement is shown as a distance d5 between theposition of end 72 in configuration (A) and its position inconfiguration (B). This movement causes the above-described movement ofventricular anchoring legs 54 away from coupling points 52. As shown,ventricular anchoring legs 54 may move the same distance d5 in responseto expansion of frame assembly 22.

For embodiments in which outer frame 60 includes ring 66, the pattern ofalternating peaks and troughs may be described as having an amplitudelongitudinally between the peaks and troughs, i.e., measured parallelwith central longitudinal axis ax1 of frame assembly 22, and thetransition between the delivery and deployed configurations may bedescribed as follows: In the delivery configuration of frame assembly 22(and in particular of inner frame tubular portion 32), the pattern ofring 66 has an amplitude d20. In the deployed configuration frameassembly 22 (and in particular of inner frame tubular portion 32), thepattern of ring 66 has an amplitude d21 that is lower than amplituded20. Because (i) it is at peaks 64 that ring 66 is coupled to innerframe 30 at coupling points 52, and (ii) it is at troughs 62 that ring66 is coupled to ventricular anchor supports 50, this reduction in theamplitude of the pattern of ring 66 moves ventricular anchor supports 50(e.g., ventricular anchoring legs 54 thereof) longitudinally furtherfrom the ventricular end of the frame assembly. The magnitude of thislongitudinal movement (e.g., the difference between magnitudes d20 andd21) is equal to d5.

In some embodiments, distance d5 is the same distance as the distancethat ventricular anchoring leg 54 moves away from coupling point 52during expansion of the frame assembly. That is, a distance betweenventricular anchoring leg 54 and the portion of ventricular anchorsupport 50 that is coupled to strut 70, may remain constant duringexpansion of the frame assembly. For some embodiments, the longitudinalmovement of ventricular anchoring leg 54 away from coupling point 52 isa translational movement (e.g., a movement that does not includerotation or deflection of the ventricular anchoring leg).

For some embodiments, a distance d6, measured parallel to axis ax1 offrame assembly 22, between coupling point 52 and first end 72 of strut70 while assembly 22 is in its delivery configuration, is 3-15 mm. Forsome embodiments, a distance d7, measured parallel to axis ax1, betweencoupling point 52 and first end 72 of strut 70 while assembly 22 is inits deployed configuration, is 1-5 mm (e.g., 1-4 mm).

For some embodiments, amplitude d20 is 2-10 mm (e.g., 4-7 mm). For someembodiments, amplitude d21 is 4-9 mm (e.g., 5-7 mm).

For some embodiments, and as shown, in the deployed configuration, firstend 72 of strut 70 is disposed closer to the ventricular end of frameassembly 22 than is coupling point 52. For some embodiments, in thedeployed configuration, first end 72 of strut 70 is disposed furtherfrom the ventricular end of frame assembly 22 than is coupling point 52.

For embodiments in which frame assembly 22 includes a plurality ofventricular anchor supports 50 and a plurality of coupling points 52(e.g., for embodiments in which the frame assembly includes outer frame60) expansion of the frame assembly increases a circumferential distancebetween adjacent coupling points 52, and an increase in acircumferential distance between adjacent ventricular anchor supports50. FIG. 3A shows such an increase in the circumferential distancebetween adjacent coupling points 52, from a circumferential distance d8in the delivery configuration to a circumferential distance d9 in thedeployed configuration. For some embodiments, distance d8 is 1-6 mm. Forsome embodiments, distance d9 is 3-15 mm.

For some embodiments, in addition to being coupled via ring 66 (e.g.,struts 70 thereof) ventricular anchor supports 50 are also connected toeach other via connectors 78. Connectors 78 allow the described movementof ventricular anchor supports 50 during expansion of frame assembly 22,but may stabilize ventricular anchor supports 50 relative to each otherwhile the frame assembly is in its deployed configuration. For example,connectors 78 may bend and/or deflect during expansion of the frameassembly. As illustrated in FIG. 3A, each ventricular anchoring leg 54may extend from junction 75 of outer frame 60. Junction 75 may be theintersection between ventricular anchoring leg 54, ventricular anchoringsupport 50, and connectors 78. Since each ventricular anchoring leg 54may extend from a separate junction 75, none of the legs 54 share acommon point of connection to outer frame 60 and annular valve body 25.Additionally or alternatively, and as illustrated in FIGS. 1B and 3A,leg portion 56, which constitutes the portion of leg 54 which extendsdirectly from junction 75, may be configured to extend upstream, in anatrial direction.

FIGS. 3B-C show structural changes in inner frame 30 during thetransitioning of frame assembly 22 between its delivery and deployedconfigurations. Inner frame tubular portion 32 of inner frame 30 isdefined by a plurality of cells 80, which are defined by the repeatingpattern of the inner frame. When frame assembly 22 is expanded from itsdelivery configuration toward its deployed configuration, cells 80 (i)widen from a width d10 to a width d11 (measured orthogonal to axis ax1of the frame assembly), and (ii) shorten from a height d12 to a heightd13 (measured parallel to axis ax1 of the frame assembly). Thisshortening reduces the overall height (i.e., a longitudinal lengthbetween atrial end 34 and ventricular end 36) of inner frame tubularportion 32 from a height d22 to a height d23, and thereby causes theabove-described longitudinal movement of upstream support portion 40toward coupling points 52 by a distance d14 (shown in FIG. 3C). Asillustrated in FIGS. 3B and 3C, coupling points 52 may be disposed atthe widest part of each cell. Because a circumferential distance betweenadjacent coupling elements 31 may be equal for all coupling elements 31(e.g., d11), a circumferential distance between adjacent atrialanchoring arms 46 may also be equal for all arms 46, since each atrialanchoring arm 46 is disposed between two adjacent coupling elements 31.Thus, atrial anchoring arms 46 may be spaced at a regular interval abouta circumference of inner frame 30 and of annular valve body 25.

Due to the configurations described herein, the distance by whichventricular anchoring legs 54 move with respect to (e.g., toward, ortoward-and-beyond) upstream support portion 40 (e.g., atrial anchoringarms 46 thereof), may be greater than the reduction in the overallheight of inner frame tubular portion 32 (e.g., more than 20 percentgreater, such as more than 30 percent greater, such as more than 40percent greater). That is, prosthetic valve 20 includes an inner frame(30) that includes an inner frame tubular portion (32) thatcircumscribes a longitudinal axis (ax1) of the inner frame so as todefine a lumen (38) along the axis, the inner frame tubular portionhaving an atrial end (34), a ventricular end (36), a longitudinal lengththerebetween, and a diameter (e.g., d1 or d2) transverse to thelongitudinal axis; a valve member (58), coupled to the inner frametubular portion, disposed within the lumen, and arranged to provideunidirectional upstream-to-downstream flow of blood through the lumen;an upstream support portion (40), coupled to the inner frame tubularportion; and an outer frame (60), coupled to the inner frame tubularportion, and including a tissue-engaging ventricular anchoring leg (54),wherein: the prosthetic valve has a first configuration (e.g., as shownin FIG. 2D and FIG. 4D) and a second configuration (e.g., as shown inFIG. 2E and FIG. 4E), in both the first configuration and the secondconfiguration, (i) the upstream support portion extends radially outwardfrom the inner frame tubular portion, and (ii) the tissue-engagingventricular anchoring leg extends radially outward from the inner frametubular portion, and the inner frame tubular portion, the upstreamsupport portion, and the outer frame are arranged such thattransitioning of the prosthetic valve from the first configurationtoward the second configuration: increases the diameter of the innerframe tubular portion by a diameter-increase amount (e.g., thedifference between d1 and d2), decreases the length of the inner frametubular portion by a length-decrease amount (e.g., the differencebetween d22 and d23), and moves the ventricular anchoring leg alongitudinal distance with respect to (e.g., toward ortoward-and-beyond) the upstream support portion (e.g., the differencebetween d3 and d4), this distance being greater than the length-decreaseamount.

As shown in the figures, inner frame 30 may be coupled to outer frame 60by coupling between (i) a valve-frame coupling element 31 defined byinner frame 30, and (ii) an outer-frame coupling element 61 defined byouter frame 60 (e.g., an outer-frame coupling element is coupled to end74 of each strut). In some embodiments, elements 31 and 61 are fixedwith respect to each other. Each coupling point 52 may be defined as thepoint at which a valve-frame coupling element and a correspondingouter-frame coupling element 61 are coupled (e.g., are fixed withrespect to each other). For some embodiments, and as shown, elements 31and 61 are eyelets configured to be coupled together by a connector,such as a pin or suture. For some embodiments, elements 31 and 61 aresoldered or welded together.

In some embodiments, and as shown, valve-frame coupling elements 31 aredefined by inner frame tubular portion 32, and are disposedcircumferentially around central longitudinal axis ax1. Outer-framecoupling elements 61 are coupled to ring 66 (or defined by frame 60,such as by ring 66) at respective peaks 64.

As shown (e.g., in FIGS. 2A-E), inner frame 30 (e.g., inner frametubular portion 32 thereof) and outer frame 60 (e.g., ring 66 thereof)are arranged in a close-fitting coaxial arrangement, in both thedeployed and delivery configurations of frame assembly 22. Ignoringspaces due to the cellular structure of the frames, a radial gap d19between inner frame 30 (e.g., inner frame tubular portion 32 thereof)and outer frame 60 (e.g., ring 66 thereof) may be less than 2 mm (e.g.,less than 1 mm), in both the delivery and deployed configurations, andduring the transition therebetween. This is facilitated by the couplingbetween frames 30 and 60, and the behavior, described hereinabove, offrame 60 in response to changes in the diameter of inner frame tubularportion 32 (e.g., rather than solely due to delivery techniques and/ortools). For some embodiments, more than 50 percent (e.g., more than 60percent) of ring 66 is disposed within 2 mm of inner frame tubularportion 32 in both the delivery and deployed configurations, and duringthe transition therebetween. For some embodiments, more than 50 percent(e.g., more than 60 percent) of outer frame 60, except for ventricularanchoring legs 54, is disposed within 2 mm of inner frame tubularportion 32 in both the delivery and deployed configurations, and duringthe transition therebetween. As illustrated in FIGS. 2A and 2C,ventricular anchoring legs 54 may be substantially flush with innerframe 30 when in the delivery configuration. This may be, at least inpart, due to the small distance d19 between inner frame 30 and outerframe 60, and due to the fact that ventricular anchoring legs 54 arearranged parallel with axis ax1 when in the delivery configuration (asexplained above).

The structural changes to frame assembly 22 (e.g., to outer frame 60thereof) are described hereinabove as they occur during (e.g., as aresult of) expansion of the frame assembly (in particular inner frametubular portion 32 thereof). This is the natural way to describe thesechanges because, as described hereinbelow with respect to FIGS. 4A-6,assembly 22 is in its delivery configuration during percutaneousdelivery to the implant site, and is subsequently expanded. However, thenature of prosthetic valve 20 may be further understood by describingstructural changes that occur during compression of the frame assembly(e.g., a transition from the deployed configuration in FIG. 2E to theintermediate configuration in FIG. 2D), in particular inner frametubular portion 32 thereof (including if inner frame tubular portion 32were compressed by application of compressive force to the inner frametubular portion, and not to frame 60 except via the inner frame tubularportion pulling frame 60 radially inward). Such descriptions may also berelevant because prosthetic valve 20 may be compressed (i.e., “crimped”)soon before its percutaneous delivery, and therefore these changes mayoccur while prosthetic valve 20 is in the care of the operatingphysician.

For some embodiments, the fixation of peaks 64 to respective sites ofinner frame tubular portion 32 is such that compression of the innerframe tubular portion from its deployed configuration toward itsdelivery configuration such that the respective sites of the inner frametubular portion pull the peaks radially inward via radially-inwardtension on coupling points 52: (i) reduces a circumferential distancebetween each of the coupling points and its adjacent coupling points(e.g., from d9 to d8), and (ii) increases the amplitude of the patternof ring 66 (e.g., from d21 to d20).

For some embodiments, the fixation of outer-frame coupling elements 61to valve-frame coupling elements 31 is such that compression of innerframe tubular portion 32 from its deployed configuration toward itsdelivery configuration such that the valve-frame coupling elements pullthe outer-frame coupling elements radially inward: (i) reduces acircumferential distance between each of the outer-frame couplingelements and its adjacent outer-frame coupling elements (e.g., from d9to d8), and (ii) increases the amplitude of the pattern of ring 66(e.g., from d21 to d20).

For some embodiments, the fixation of peaks 64 to the respective sitesof inner frame tubular portion 32 is such that compression of the innerframe tubular portion from its deployed configuration toward itsdelivery configuration (i) pulls the peaks radially inward viaradially-inward pulling of the respective sites of the inner frametubular portion on the peaks, (ii) reduces a circumferential distancebetween each of coupling points 52 and its adjacent coupling points(e.g., from d9 to d8), and (iii) increases the amplitude of the patternof ring 66 (e.g., from d21 to d20), without increasing radial gap d19between inner frame 30 (e.g., inner frame tubular portion 32 thereof)and the ring by more than 1.5 mm.

For some embodiments, the fixation of outer-frame coupling elements 61with respect to valve-frame coupling elements 31 is such thatcompression of inner frame tubular portion 32 from its deployedconfiguration toward its delivery configuration (i) pulls outer-framecoupling elements 61 radially inward via radially-inward pulling ofvalve-frame coupling elements 31 on outer-frame coupling elements 61,(ii) reduces a circumferential distance between each of the outer-framecoupling elements and its adjacent outer-frame coupling elements (e.g.,from d9 to d8), and (iii) increases the amplitude of the pattern of ring66 (e.g., from d21 to d20), without increasing radial gap d19 betweeninner frame 30 (e.g., inner frame tubular portion 32 thereof) and thering by more than 1.5 mm.

Reference is made to FIGS. 4A-F, which are schematic illustrations ofimplantation of prosthetic valve 20 at a native valve 10 of a heart 4 ofa subject, in accordance with some embodiments of the invention. Valve10 is shown as a mitral valve of the subject, disposed between a leftatrium 6 and a left ventricle 8 of the subject. However prosthetic valve20 may be implanted at another heart valve of the subject, mutatismutandis. Similarly, although FIGS. 4A-F show prosthetic valve 20 beingdelivered transseptally via a sheath 88, the prosthetic valve mayalternatively be delivered by any other suitable route, such astransatrially, or transapically.

Prosthetic valve 20 is delivered, in its delivery configuration, tonative valve 10 using a delivery device 89 that is operable from outsidethe subject (FIG. 4A). In some embodiments, prosthetic valve 20 isdelivered within a delivery capsule 90 of device 89, which retains theprosthetic valve in its delivery configuration. A transseptal approach,such as a transfemoral approach, is shown. In some embodiments,prosthetic valve 20 is positioned such that at least ventricularanchoring legs 54 are disposed downstream of the native valve (i.e.,within ventricle 8). At this stage, frame assembly 22 of prostheticvalve 20 is as shown in FIG. 2A.

Subsequently, ventricular anchoring legs 54 are allowed to protruderadially outward, as described hereinabove, e.g., by releasing them fromcapsule 90 (FIG. 4B). For example, and as shown, capsule 90 may includea distal capsule-portion 92 and a proximal capsule-portion 94, and thedistal capsule-portion may be moved distally with respect to prostheticvalve 20, so as to expose ventricular anchoring legs 54. At this stage,frame assembly 22 of prosthetic valve 20 is as shown in FIG. 2B.

Subsequently, prosthetic valve 20 is moved upstream, such that upstreamsupport portion 40, in its delivery configuration, is disposed upstreamof leaflets 12 (i.e., within atrium 6). As illustrated in FIGS. 4C and4D, the upstream movement of prosthetic valve 20 causes ventricularanchoring legs 54 to engage ventricular tissue of valve 10 when legs 54are in the deployed configuration. In particular, ventricular anchoringlegs 54 may engage leaflets 12 on the ventricular side of valve 10.However, because of the relatively large distance d3 provided byprosthetic valve 20 (described hereinabove), for some embodiments it maynot be necessary to move the prosthetic valve so far upstream thatventricular anchoring legs 54 tightly engage leaflets 12 and/or pull theleaflets upstream of the valve annulus. Upstream support portion 40 isthen allowed to expand such that it protrudes radially outward, asdescribed hereinabove, e.g., by releasing it from capsule 90 (FIG. 4D).For example, and as shown, proximal capsule-portion 94 may be movedproximally with respect to prosthetic valve 20, so as to expose upstreamsupport portion 40. At this stage, frame assembly 22 of prosthetic valve20 is as shown in FIG. 2D, in which: (i) distance d3 exists betweenupstream support portion 40 and ventricular anchoring legs 54, (ii) theventricular anchoring legs have span d15, (iii) the upstream supportportion has span d17, and (iv) inner frame tubular portion 32 hasdiameter d1.

In some embodiments, expansion of frame assembly 22 is inhibited bydistal capsule-portion 92 (e.g., by inhibiting expansion of inner frametubular portion 32), and/or by another portion of delivery device 89(e.g., a portion of the delivery tool that is disposed within lumen 38).

Subsequently, prosthetic valve 20 is allowed to expand toward itsdeployed configuration, such that inner frame tubular portion 32 widensto diameter d2, and the distance between upstream support portion 40 andventricular anchoring legs 54 reduces to distance d4 (FIG. 4E). Thissandwiches tissue of valve 10 (in some embodiments including annulartissue and/or leaflets 12) between upstream support portion 40 andventricular anchoring legs 54, thereby securing prosthetic valve 20 atthe valve. FIG. 4F shows delivery capsule 90 having been removed fromthe body of the subject, leaving prosthetic valve 20 in place at valve10.

As described hereinabove, prosthetic valve 20 is configured such thatwhen inner frame tubular portion 32 is expanded, ventricular anchoringlegs 54 and upstream support portion 40 move a relatively large distancetoward each other. This enables distance d3 to be relatively large,while distance d4 is sufficiently small to provide effective anchoring.As also described hereinabove, prosthetic valve 20 is configured suchthat ventricular anchoring legs 54 and upstream support portion 40 canextend radially outward a relatively large distance while inner frametubular portion 32 remains compressed. It is hypothesized that for someembodiments, these configurations (independently and/or together)facilitate effective anchoring of prosthetic valve 20, by facilitatingplacement of a relatively large proportion of valve tissue (e.g.,leaflets 12) between the ventricular anchoring legs and the upstreamsupport portion prior to expanding inner frame tubular portion 32 andsandwiching the valve tissue.

It is further hypothesized that the relatively great radially-outwardextension of ventricular anchoring legs 54 and upstream support portion40 prior to expansion of inner frame tubular portion 32, furtherfacilitates the anchoring/sandwiching step by reducing radially-outwardpushing of the valve tissue (e.g., leaflets 12) during the expansion ofthe inner frame tubular portion, and thereby increasing the amount ofvalve tissue that is sandwiched.

It is yet further hypothesized that this configuration of prostheticvalve 20 facilitates identifying correct positioning of the prostheticvalve (i.e., with upstream support portion 40 upstream of leaflets 12and ventricular anchoring legs 54 downstream of the leaflets) prior toexpanding inner frame tubular portion 32 and sandwiching the valvetissue.

As shown in FIG. 1A, for some embodiments, in the deployed configurationof frame assembly 22, prosthetic valve 20 defines a toroidal space 49between ventricular anchoring legs 54 and upstream support portion 40(e.g., a space that is wider than distance d4). For example, space 49may have a generally triangular cross-section. It is hypothesized thatfor some such embodiments, in addition to sandwiching tissue of thenative valve between upstream support portion 40 and ventricularanchoring legs 54 (e.g., the tips of the ventricular anchoring legs),space 49 advantageously promotes tissue growth therewithin (e.g.,between leaflet tissue and covering 23), which over time further securesprosthetic valve 20 within the native valve.

Reference is now made to FIG. 5, which is a schematic illustration of astep in the implantation of prosthetic valve 20, in accordance with someembodiments of the invention. Whereas FIGS. 4A-F show an implantationtechnique in which ventricular anchoring legs 54 are expanded prior toupstream support portion 40, for some embodiments the upstream supportportion is expanded prior to the ventricular anchoring legs. FIG. 5shows a step in such an embodiment.

Reference is again made to FIGS. 2A-5. As noted hereinabove, prostheticvalve 20 may be implanted by causing ventricular anchoring legs 54 toradially protrude before causing upstream support portion 40 to radiallyprotrude, or may be implanted by causing the upstream support portion toprotrude before causing the ventricular anchoring legs to protrude. Forsome embodiments, prosthetic valve 20 is thereby configured to bedeliverable in a downstream direction (e.g., transseptally, as shown, ortransapically) or in an upstream direction (e.g., transapically or viathe aortic valve). Thus, for some embodiments, an operating physicianmay decide which delivery route is preferable for a given application(e.g., for a given subject, and/or based on available equipment and/orexpertise), and prosthetic valve 20 is responsively prepared for thechosen delivery route (e.g., by loading the prosthetic valve into anappropriate delivery tool).

It is to be noted that for some embodiments, downstream delivery ofprosthetic valve 20 may be performed by expanding ventricular anchoringlegs 54 first (e.g., as shown in FIGS. 4A-F) or by expanding upstreamsupport portion 40 first (e.g., as shown in FIG. 5). Similarly, for someembodiments upstream delivery of prosthetic valve 20 may be performed byupstream support portion 40 first, or by expanding ventricular anchoringlegs 54 first.

Reference is now made to FIG. 6, which is a schematic illustration ofprosthetic valve 20, in the configuration and position shown in FIG. 4D,in accordance with some embodiments of the invention. For someembodiments, while prosthetic valve 20 is in the configuration andposition shown in FIG. 4D, leaflets 12 of valve 10 are able to move, atleast in part in response to beating of the heart. Frame (A) showsleaflets 12 during ventricular systole, and frame (B) shows the leafletsduring ventricular diastole. For some such embodiments, blood is therebyable to flow from atrium 6 to ventricle 8, between leaflets 12 andprosthetic valve 20. It is hypothesized that this advantageouslyfacilitates a more relaxed implantation procedure, e.g., facilitatingretaining of prosthetic valve 20 in this configuration and position fora duration of greater than 8 minutes. During this time, imagingtechniques may be used to verify the position of prosthetic valve 20,and/or positioning of leaflets 12 between upstream support portion 40and ventricular anchoring legs 54.

Reference is made to FIGS. 7A-B and 8A-B, which are schematicillustrations of frame assemblies 122 and 222 of respective prostheticvalves, in accordance with some embodiments of the invention. Exceptwhere noted otherwise, frame assemblies 122 and 222 may be identical toframe assembly 22, mutatis mutandis. Elements of frame assemblies 122and 222 share the name of corresponding elements of frame assembly 22.Additionally, except where noted otherwise, the prosthetic valves towhich frame assemblies 122 and 222 belong are similar to prostheticvalve 20, mutatis mutandis.

Frame assembly 122 includes an inner frame 130 having an inner frametubular portion 132 and an upstream support portion 140 which mayinclude a plurality of atrial anchoring arms 146. Inner frame 130 mayhave an atrial end 134, a ventricular end 136, and an intermediateportion extending between the atrial and ventricular ends. Frameassembly 122 may also include an outer frame 160 that circumscribesinner frame 130. Outer frame 160 may have an atrial end 167, aventricular end 169, and an intermediate portion extending between theatrial and ventricular ends. Outer frame 160 may include an outer frametubular portion 165 having a plurality of ventricular anchor supports150, from which a plurality of ventricular anchoring legs 154 mayextend. In particular, and as illustrated in FIG. 7B, ventricularanchoring legs 154 may extend from the intermediate portion of outerframe 160. Inner frame tubular portion 132 and outer frame tubularportion 165 may form annular valve body 125, which may include an atrialend, a ventricular end, and an intermediate portion extending betweenthe atrial and ventricular ends. In some embodiments, atrial end 134 ofinner frame 130 may form the atrial end of annular valve body 125. Insome embodiments, ventricular end 136 of inner frame 130 and ventricularend 169 of outer frame 160 may form the ventricular end of annular valvebody 125. In some embodiments, inner frame 130 may extend upstream in anatrial direction beyond the atrial end 167 of outer frame 160. In someembodiments, outer frame 160 includes a ring 166 to which ventricularanchor supports 150 are coupled. Ring 166 is defined by a pattern ofalternating peaks and troughs, the peaks being fixed to frame 130 atrespective coupling points 152, e.g., as described hereinabove for frameassembly 22, mutatis mutandis.

Frame assembly 222 includes (i) an inner frame 230 that includes aninner frame tubular portion 232 and an upstream support portion 240which may include a plurality of atrial anchoring arms 246, and (ii) anouter frame 260 that circumscribes the inner frame, and includes aplurality of ventricular anchor supports 250 that each may include aventricular anchoring leg. In some embodiments, outer frame 260 includesa ring 266 to which ventricular anchor supports 250 are coupled. Ring266 is defined by a pattern of alternating peaks and troughs, the peaksbeing fixed to frame 230 at respective coupling points 252, e.g., asdescribed hereinabove for frame assembly 22, mutatis mutandis.

Whereas atrial anchoring arms 46 of frame assembly 22 are shown asextending from atrial end 34 of inner frame tubular portion 32, atrialanchoring arms 146 and 246 of frame assemblies 122 and 222,respectively, extend from sites downstream from atrial ends 134, 234.(This difference may also be made to frame assembly 22, mutatismutandis.) For example, and as illustrated in FIG. 7B, atrial anchoringarms 146 and ventricular anchoring legs 154 may extend from anintermediate portion of annular valve body 125, between atrial end 134and ventricular end 136 thereof. In particular, and as illustrated inFIG. 7B, atrial anchoring arms 146 may extend from the intermediateportion of inner frame 130. Inner frame tubular portions 32, 132 and 232are each defined by a repeating pattern of cells that extends around thecentral longitudinal axis. In some embodiments, and as shown, innerframe tubular portions 32, 132 and 232 are each defined by two stacked,tessellating rows of cells. In the deployed configuration of the innerframe tubular portion, these cells may be narrower at their upstream anddownstream extremities than midway between these extremities. Forexample, and as shown, the cells may be roughly diamond or astroid inshape. In frame assembly 22, each atrial anchoring arm 46 is attached toand extends from a site 35 that is at the upstream extremity of cells ofthe upstream row. In contrast, in frame assemblies 122 and 222, eachatrial anchoring arm 146 or 246 is attached to and extends from a site135 (assembly 122) or 235 (assembly 222) that is at the connectionbetween two adjacent cells of the upstream row (alternatively describedas being at the upstream extremity of cells of the downstream row).

It is hypothesized by the inventors that this lower position of theatrial anchoring arms, while maintaining the length of the lumen of theinner frame tubular portion, advantageously reduces the distance thatthe inner frame tubular portion (i.e., the ventricular end thereof)extends into the ventricle of the subject, and thereby reduces alikelihood of inhibiting blood flow out of the ventricle through theleft ventricular outflow tract. It is further hypothesized that thisposition of the atrial anchoring arms reduces radial compression of theinner frame tubular portion by movement of the heart, due to greaterrigidity of the inner frame tubular portion at sites 135 and 235 (whichis supported by two adjacent cells) than at site 35 (which is supportedby only one cell).

As shown, in the deployed configuration of frame assemblies 22, 122 and222, the ventricular anchor supports (50, 150 and 250, respectively) arecircumferentially staggered with the atrial anchoring arms of theupstream support portion (46, 146 and 246, respectively). This allowsthe ventricular anchor supports to move in an upstream direction betweenthe atrial anchoring arms during expansion of the inner frame tubularportion (32, 132 and 232, respectively), facilitating application ofgreater sandwiching force on tissue of the native valve. The lowerposition of the atrial anchoring arms of assemblies 122 and 222 includescircumferentially shifting the position of the atrial anchoring arms bythe width of half a cell. In order to maintain the circumferentialstaggering of the atrial anchoring arms and ventricular anchor supports,rings 166 and 266 (and thereby ventricular anchor supports 150 and 250)are circumferentially shifted correspondingly. As a result, whereas thepeaks of ring 66 generally align with connections between adjacent cellsof the downstream row of cells of inner frame tubular portion 32 (andare fixed to these sites), the peaks of rings 166 and 266 are generallyaligned midway between these sites (i.e., at spaces of the cellularstructure of the inner frame tubular portion). An appendages 168 (forassembly 122) or 268 (for assembly 222) facilitate fixing of the peakwith respect to the tubular structure.

For assembly 122, appendages 168 are defined by inner frame 130 (e.g.,by inner frame tubular portion 132 thereof) and extend (in a downstreamdirection) to the peaks of ring 166, to which they are fixed. Forexample, each appendage 168 may define a valve-frame coupling element131 that is fixed to a respective outer-frame coupling element 161defined by outer frame 260. In some embodiments, appendages 168 extendfrom sites 135. In some embodiments, appendages 168 are integral withinner frame tubular portion 132 and/or in-plane with the inner frametubular portion (e.g., are part of its tubular shape).

For assembly 222, appendages 268 are defined by outer frame 260, andextend (e.g., in an upstream direction) from the peaks of ring 266. Insome embodiments, appendages 268 extend to sites 235, to which they arefixed. For example, each appendage 268 may define an outer-framecoupling element 261 that is fixed to a respective valve-frame couplingelement 231 defined by inner frame 230 (e.g., by inner frame tubularportion 232 thereof). In some embodiments, appendages 268 are integralwith outer frame 260 and/or in-plane with adjacent portions of outerframe 260, such as ring 266.

Therefore, frame assembly 122 defines a hub at site 135, and frameassembly 222 defines a hub at site 235. For some embodiments, apparatustherefore includes: a plurality of prosthetic valve leaflets; and aframe assembly, including: an inner frame tubular portion (132 or 232)defined by a repeating pattern of cells, the inner frame tubular portionextending circumferentially around longitudinal axis ax1 so as to definea longitudinal lumen, the prosthetic valve leaflets coupled to the innerframe and disposed within the lumen; an outer frame (160 or 260),including a plurality of ventricular anchor supports (150 or 250),distributed circumferentially around the inner frame tubular portion,each ventricular anchor support having a ventricular anchoring leg (154or 254); an upstream support portion (140 or 240) that includes aplurality of atrial anchoring arms (146 or 246) that extend radiallyoutward from the inner frame tubular portion; and a plurality ofappendages (168 or 268), each having a first end that defines a couplingelement (161 or 261) via which the inner frame tubular portion iscoupled to the outer frame, and a second end; wherein the frame assemblydefines a plurality of hubs (135 or 235), distributed circumferentiallyaround the longitudinal axis on a plane that is transverse tolongitudinal axis ax1, each hub defined by convergence and connectionof, (i) two adjacent cells of the inner frame tubular portion, (ii) anarm of the plurality of atrial anchoring arms, and (iii) an appendage ofthe plurality of appendages.

Reference is made to FIGS. 9A-C, which are schematic illustrations of anprosthetic valve 320 including a frame assembly 322, in accordance withsome embodiments of the invention. Except where noted otherwise, frameassembly 322 is identical to frame assembly 122, and prosthetic valve300 is identical to the prosthetic valve to which frame assembly 122belongs, mutatis mutandis. FIG. 9A is a side-view of prosthetic valve320, and FIG. 9B is an isometric bottom-view of the prosthetic valve.

Frame assembly 122 includes (i) an inner frame 330 that includes aninner frame tubular portion 332 and an upstream support portion 340which may include a plurality of atrial anchoring arms 346, and (ii) anouter frame 360 that circumscribes the inner frame, and includes aplurality of ventricular anchor supports 350 that each may include aventricular anchoring leg 354. In some embodiments, outer frame 360includes a ring 366 to which ventricular anchor supports 350 arecoupled. Ring 366 is defined by a pattern of alternating peaks andtroughs, the peaks being fixed to frame 330 at respective couplingpoints 352, e.g., as described hereinabove for frame assembly 22 and/orframe assembly 122, mutatis mutandis.

Frame assembly 322 includes an annular upstream support portion 340 thathas an inner portion 342 that extends radially outward from the upstreamportion (e.g., the atrial end) of inner frame tubular portion 332.Upstream support portion 340 further includes one or more fabric pockets344 disposed circumferentially around inner portion 342, each pocket ofthe one or more pockets having an opening that faces a downstreamdirection (i.e., generally toward the ventricular end of prostheticvalve 320). In the figures, upstream support portion 340 has a singletoroidal pocket 344 that extends circumferentially around inner portion342.

In some embodiments, a covering 323 (e.g., similar to covering 23,described hereinabove, mutatis mutandis) is disposed over atrialanchoring arms 346, thereby forming pocket 344. Further in someembodiments, atrial anchoring arms 346 are shaped to form pocket 344from covering 323. For example, and as shown, atrial anchoring arms 346may curve to form a hook-shape.

For some embodiments, portion 340 has a plurality of separate pockets344, e.g., separated at atrial anchoring arms 346. For some suchembodiments, covering 323 is loosely-fitted (e.g., baggy) betweenradially-outward parts of atrial anchoring arms 346, e.g., compared toinner portion 342, in which the covering is more closely-fitted betweenradially-inward parts of the atrial anchoring arms.

FIG. 9C shows prosthetic valve 320 implanted at native valve 10. Pocket344 may be shaped and arranged to billow in response to perivalvularflow 302 of blood in an upstream direction. If ventricular systoleforces blood in ventricle 8 between prosthetic valve 320 and nativevalve 10, that blood inflates pocket 344 and presses it (e.g., covering323 and/or the radially-outward part of atrial anchoring arm 346)against tissue of atrium 6 (e.g., against the atrial wall), therebyincreasing sealing responsively. It is hypothesized by the inventorsthat the shape and orientation of pocket 344 (e.g., the hook-shape ofatrial anchoring arms 346) facilitates this pressing radially-outward inresponse to the pocket's receipt of upstream-flowing blood.

Pocket(s) 344 may be used in combination with any of the prostheticvalves described herein, mutatis mutandis.

Reference is again made to FIGS. 1A-9C. It is to be noted that unlessspecifically stated otherwise, the term “radially outward” (e.g., usedto describe upstream support portion 40 and ventricular anchoring legs54) means portions of the element are disposed progressively furtheroutward from a central point (such as longitudinal axis ax1 or innerframe tubular portion 32), but does not necessarily mean disposed at 90degrees with respect to longitudinal axis ax1. For example, ventricularanchoring legs 54 may extend radially outward at 90 degrees with respectto longitudinal axis ax1 when in the deployed configuration, but mayalternatively extend radially outward at a shallower angle with respectto the longitudinal axis when in the deployed configuration.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. An expandable prosthetic valve forimplantation within a native mitral valve, the prosthetic valvecomprising: an expandable annular valve body having: an annular outerframe including an atrial end, a ventricular end opposite the atrialend, and an intermediate portion extending between the atrial end andthe ventricular end, and an inner frame positioned at least partiallywithin the annular outer frame, the inner frame including an atrial end,a ventricular end opposite the atrial end, and an intermediate portionextending between the atrial end and the ventricular end; a plurality ofatrial anchoring arms configured to extend from the annular valve body,each atrial anchoring arm comprising a proximal arm end secured to theannular valve body and a terminal arm end opposite from the proximal armend; and a plurality of ventricular anchoring legs configured to extendfrom the annular valve body, wherein at least one ventricular anchoringleg is configured to extend from the intermediate portion of the annularouter frame and is configured to assume: a leg delivery configuration inwhich the ventricular anchoring leg is radially constrained within adelivery device, and a deployed-leg configuration in which theventricular anchoring leg pivots radially outward about a connectionpoint of the ventricular anchoring leg to the annular valve body by lessthan 90° from the delivery configuration, and wherein at least one ofthe plurality of atrial anchoring arms is configured to extend from theintermediate portion of the inner frame and is configured to assume: anarm delivery configuration in which the atrial anchoring arm is radiallyconstrained within the delivery device such that a portion of the atrialanchoring arm extends from the annular valve body towards an atrium in afirst arm direction, and a deployed-arm configuration in which theportion of the atrial anchoring arm deflects radially outward to extendfrom the annular valve body towards a ventricle in a second armdirection, the second arm direction forming an angle of at least 90°with the first arm direction.
 2. The prosthetic valve of claim 1,wherein the entire length of the at least one ventricular anchoring legis configured to extend toward the atrium when the at least oneventricular anchoring leg is in the leg delivery configuration and inthe deployed-leg configuration.
 3. The prosthetic valve of claim 1,wherein the at least one ventricular anchoring leg is configured toextend toward the atrium in a direction substantially parallel to alongitudinal axis of the expandable annular valve body when the at leastone ventricular anchoring leg is in the leg delivery configuration. 4.The prosthetic valve of claim 1, wherein a first portion of the at leastone atrial anchoring arm is configured to extend away from the ventricleand a second portion of the at least one atrial anchoring arm isconfigured to extend toward the ventricle.
 5. The prosthetic valve ofclaim 4, wherein the first portion of the at least one atrial anchoringarm is configured to be positioned radially outwards from the secondportion of the at least one atrial anchoring arm when the at least oneatrial anchoring arm is in the deployed-arm configuration.
 6. Theprosthetic valve of claim 1, wherein at least a portion of the at leastone ventricular anchoring leg is configured to be substantially flushwith the expandable annular valve body when the at least one ventricularanchoring leg is in the leg delivery configuration.
 7. The prostheticvalve of claim 1, wherein the plurality of atrial anchoring arms areconfigured to be spaced at a regular interval about a circumference ofthe annular valve body; and wherein the plurality of ventricularanchoring legs are configured to be spaced at a regular interval about acircumference of the annular valve body.
 8. The prosthetic valve ofclaim 1, wherein the plurality of ventricular anchoring legs extendsfrom the annular outer frame and the plurality of atrial anchoring armsextend from the inner frame.
 9. The prosthetic valve of claim 1, whereinat least a portion of the at least one ventricular anchoring leg isconfigured to be substantially flush with the inner frame when the atleast one ventricular anchoring leg is in the leg deliveryconfiguration.
 10. The prosthetic valve of claim 1, wherein the at leastone ventricular anchoring leg extends from a single connection point tothe expandable annular valve body, and wherein none of the ventricularanchoring legs share a common connection point to the expandable annularvalve body.
 11. The prosthetic valve of claim 1, wherein a portion ofthe at least one ventricular anchoring leg is configured to besubstantially flush with the inner frame when the at least oneventricular anchoring leg is in the leg delivery configuration.
 12. Theprosthetic valve of claim 1, wherein the inner frame is configured toextend in an atrial direction beyond the atrial end of the annular outerframe.
 13. An expandable prosthetic valve, comprising: an annular valvebody having: an annular outer frame including an atrial end, aventricular end opposite the atrial end, and an intermediate portionextending between the atrial end and the ventricular end, and an innerframe positioned at least partially within the annular outer frame; aplurality of atrial anchoring arms configured to extend from the annularvalve body, each atrial anchoring arm comprising a proximal arm endsecured to the annular valve body and a terminal arm end opposite fromthe proximal arm end; and a plurality of ventricular anchoring legsconfigured to extend from the annular valve body, wherein at least oneventricular anchoring leg is configured to extend from the intermediateportion of the annular outer frame and is configured to assume: a legdelivery configuration in which the ventricular anchoring leg isarranged along a leg-extension axis substantially parallel to alongitudinal axis of the annular valve body, and a deployed-legconfiguration in which the ventricular anchoring leg pivots radiallyoutward about a connection point of the ventricular anchoring leg to theannular valve body by less than 90° from the leg-extension axis, andwherein at least one of the plurality of atrial anchoring arms isconfigured to extend from the inner frame and is configured to assume:an arm delivery configuration in which the atrial anchoring arm extendsfrom the annular valve body towards an atrium in a first arm directionsubstantially parallel to the longitudinal axis of the annular valvebody, and a deployed-arm configuration in which a portion of the atrialanchoring arm deflects radially outward to extend from the annular valvebody towards a ventricle in a second arm direction, the second armdirection forming an angle of at least 90° with the first arm direction,wherein when the at least one atrial anchoring arm is arranged in thedeployed-arm configuration, the atrial anchoring arm is configured toextend radially outward from the annular valve body such that theterminal arm end forms an outer-most portion of the atrial anchoringarm.
 14. The prosthetic valve of claim 13, wherein the at least oneatrial anchoring arm includes a second portion which is configured todeflect radially outward by less than 90° when the at least one atrialanchoring arm moves from the arm delivery configuration to thedeployed-arm configuration.
 15. The prosthetic valve of claim 1, whereinthe at least one atrial anchoring arm is configured to deflect radiallyoutwards independent of radial deflection of the other atrial anchoringarms.
 16. The prosthetic valve of claim 13, wherein the at least oneatrial anchoring arm is configured to deflect radially outwardsindependent of radial deflection of the other atrial anchoring arms.